Journal articles: 'FDA problems'

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&NA;. "FDA: ADHD Meds May Increase Heart Problems." Nurse Practitioner 31, no. 4 (April 2006): 70. http://dx.doi.org/10.1097/00006205-200604000-00026.

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&NA;. "FDA Takes Aim at Infusion Pump Problems." Journal of Clinical Engineering 35, no. 4 (October 2010): 174. http://dx.doi.org/10.1097/jce.0b013e3181fdb42b.

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Gutman, Steven I., Janie G. Fuller, and Ethan D. Hausman. "Consumers Report Glucose Meter Problems to FDA." Diabetes Technology & Therapeutics 6, no. 6 (December 2004): 767–69. http://dx.doi.org/10.1089/dia.2004.6.767.

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Kuehn, Bridget M. "FDA: Acetaminophen May Trigger Serious Skin Problems." JAMA 310, no. 8 (August 28, 2013): 785. http://dx.doi.org/10.1001/jama.2013.276938.

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Haffner, Marlene E., and John V. Kelsey. "Evaluation of Orphan Products by the U.S. Food and Drug Administration." International Journal of Technology Assessment in Health Care 8, no. 4 (1992): 647–57. http://dx.doi.org/10.1017/s0266462300002348.

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AbstractOrphan drug products generally are used in treating or preventing rare diseases. The small number of patients available for study may create special problems in the evaluation of these products. This paper examines some of the special problems that are associated with the design and implementation of studies to evaluate the safety and efficacy of orphan drugs. The U.S. Food and Drug Administration (FDA) has not established special criteria for evaluating orphan drugs per se, but the FDA has been flexible in evaluating drug products that present special problems, especially when these products are for treatment of serious of life-threatening illnesses. The FDA and other U.S. governmental agencies also have taken steps to promote the development and availability of drugs for rare diseases, including making these products available to patients who are in need, even before the drugs have full FDA marketing approval.

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Mook, Hailey. "FDA warns about dental problems associated with buprenorphine medications." Pharmacy Today 28, no. 4 (April 2022): 49. http://dx.doi.org/10.1016/j.ptdy.2022.03.021.

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Gershon, Diane. "FDA panel sees problems with labelling of milk hormone." Nature 363, no. 6425 (May 1993): 107. http://dx.doi.org/10.1038/363107a0.

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Muni, Neal I., and Thomas P. Gross. "Problems with Drug-Eluting Coronary Stents — The FDA Perspective." New England Journal of Medicine 351, no. 16 (October 14, 2004): 1593–95. http://dx.doi.org/10.1056/nejmp048262.

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Ault Barnett, Alicia. "FDA warns Pfizer on failure to report drug problems." Lancet 347, no. 9014 (June 1996): 1546. http://dx.doi.org/10.1016/s0140-6736(96)90694-7.

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Han, Ling-Na, Kai-Qiang Wang, Zi-Ning Ren, Xue Yang, Xiao Duan, Sasirekha Krishnan, Abinaya Jaisankar, et al. "One-pot synthesis and enzyme-responsiveness of amphiphilic doxorubicin prodrug nanomicelles for cancer therapeutics." RSC Advances 12, no. 43 (2022): 27963–69. http://dx.doi.org/10.1039/d2ra04436f.

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A doxorubicin-based nanomedicine with a one-pot synthesis method and FDA-approved materials could solve the problems of a complicated preparation process and avoid the use of non-FDA-approved materials for clinical use and industrial production.

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Halabi, Sam F. "The Codex Alimentarius Commission, Corporate Influence, and International Trade: A Perspective on FDA's Global Role." American Journal of Law & Medicine 41, no. 2-3 (May 2015): 406–21. http://dx.doi.org/10.1177/0098858815591525.

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The FDA Food Safety Modernization Act (FSMA) is by all accounts the most sweeping and comprehensive update to U.S. food laws in seventy years, aiming to confront the reality that the nation's food supply has undergone fundamental shifts in its sources, distribution channels, and intermediate handlers. The law's intent is to prevent problems that can cause foodborne illness and enable the Food and Drug Administration (FDA) to keep a record of facilities processing food for sale in the United States, a mandate that expands FDA's already global regulatory activities. FSMA gives FDA broad new powers to prevent food safety problems, detect and respond to food safety issues, and improve the safety of imported foods. Because the law specifically aims to update FDA authority in light of the reality of global food and food additive markets, Section 305 FSMA calls for FDA to develop a comprehensive plan to expand the “technical, scientific, and regulatory capacity of foreign governments and their respective food industries in countries that export foods to the United States.”

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Liu, Qinghua, Kai Ding, Bingsen Wu, and Quanmin Xie. "Frequency Diverse Array Target Localization Based on IPSO-BP." International Journal of Antennas and Propagation 2020 (August 27, 2020): 1–8. http://dx.doi.org/10.1155/2020/2501731.

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For the traditional target localization algorithms of frequency diverse array (FDA), there are some problems such as angle and distance coupling in single-frequency receiving FDA mode, large amount of calculation, and weak adaptability. This paper introduces a good learning and predictive method of target localization by using BP neural network on FDA, and FDA-IPSO-BP neural network algorithm is formed. The improved particle swarm optimization (IPSO) algorithm with nonlinear weights is developed to optimize the neural network weights and biases to prevent BP neural network from easily falling into local minimum points. In addition, the decoupling of angle and distance with single frequency increment is well solved. The simulation experiments show that the proposed algorithm has better target localization effect and convergence speed, compared with FDA-BP and FDA-MUSIC algorithms.

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Tanne, Janice Hopkins. "FDA works with US health insurers to identify drug problems." BMJ 336, no. 7650 (April 24, 2008): 913.2–913. http://dx.doi.org/10.1136/bmj.39559.404560.db.

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Young, Donna. "ASHP, other groups, advise FDA about solving counterfeit drug problems." American Journal of Health-System Pharmacy 60, no. 23 (December 1, 2003): 2406. http://dx.doi.org/10.1093/ajhp/60.23.2406.

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Lew, Helen, William D. Hadesty, Karen D. Bell, Francine M. DelVecchio, and Susan T. Chin. "fda import automation: Serious management and systems development problems persist." Information & Management 30, no. 3 (June 1996): 143–53. http://dx.doi.org/10.1016/0378-7206(95)00058-5.

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Mitka, M. "FDA Advisory Decision Highlights Some Problems Inherent in Pragmatic Trials." JAMA: The Journal of the American Medical Association 306, no. 17 (November 1, 2011): 1851–52. http://dx.doi.org/10.1001/jama.2011.1570.

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Springer, Janet A., and Foster D. Mcclure. "Statistical Sampling Approaches." Journal of AOAC INTERNATIONAL 71, no. 2 (March 1, 1988): 246–50. http://dx.doi.org/10.1093/jaoac/71.2.246.

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Abstract This article describes basic sampling principles and the application of statistical sampling techniques to specific problems encountered in the Food and Drug Administration (FDA). Concepts are emphasized, and theory is minimized. The basic principles of sampling from a normal and binomial population, including confidence interval calculation and sample size determination, are briefly reviewed. Stratified, random, systematic, and judgment sampling are explained. Operating characteristic curves for attribute (and perhaps variable) sampling for acceptance of lots are derived and applied to specific FDA problems. The advantages and disadvantages of single and multiple sampling plans and plans which address multiple classes of criteria such as major and minor defects are discussed. Sampling schedules such as MIL-STD-105D and Canada's Government Specifications Board CGSB-105-GP-1 are reviewed to familiarize readers with the principles involved in these plans and to give them an idea of how they could be applied to FDA problems.

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Reed, Terrie L., and Diana Kaufman-Rivi. "FDA Adverse Event Problem Codes: Standardizing the Classification of Device and Patient Problems Associated with Medical Device Use." Biomedical Instrumentation & Technology 44, no. 3 (May 1, 2010): 248–56. http://dx.doi.org/10.2345/0899-8205-44.3.248.

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Abstract The broad array of medical devices and the potential for device failures, malfunctions, and other adverse events associated with each device creates a challenge for public health device surveillance programs. Coding reported events by type of device problem provides one method for identifying a potential signal of a larger device issue. The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) Event Problem Codes that are used to report adverse events previously lacked a structured set of controls for code development and maintenance. Over time this led to inconsistent, ambiguous, and duplicative concepts being added to the code set on an ad-hoc basis. Recognizing the limitation of its coding system the FDA set out to update the system to improve its usefulness within FDA and as a basis of a global standard to identify important patient and device outcomes throughout the medical community. Methods: In 2004, FDA and the National Cancer Institute (NCI) signed a Memorandum of Understanding (MOU) whereby NCI agreed to provide terminology development and maintenance services to all FDA Centers. Under this MOU, CDRH's Office of Surveillance and Biometrics (OSB) convened a cross-Center workgroup and collaborated with staff at NCI Enterprise Vocabulary Service (EVS) to streamline the Patient and Device Problem Codes and integrate them into the NCI Thesaurus and Meta-Thesaurus. This initiative included many enhancements to the Event Problem Codes aimed at improving code selection as well as improving adverse event report analysis. Limitations & Recommendations: Staff resources, database concerns, and limited collaboration with external groups in the initial phases of the project are discussed. Conclusions: Adverse events associated with medical device use can be better understood when they are reported using a consistent and well-defined code set. This FDA initiative was an attempt to improve the structure and add control mechanisms to an existing code set, improve analysis tools that will better identify device safety trends, and improve the ability to prevent or mitigate effects of adverse events associated with medical device use.

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Wang, Yintong, Jiandong Wang, Haiyan Chen, and Bo Sun. "Semi-Supervised Local Fisher Discriminant Analysis Based on Reconstruction Probability Class." International Journal of Pattern Recognition and Artificial Intelligence 29, no. 02 (February 27, 2015): 1550007. http://dx.doi.org/10.1142/s021800141550007x.

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Fisher discriminant analysis (FDA) is a classic supervised dimensionality reduction method in statistical pattern recognition. FDA can maximize the scatter between different classes, while minimizing the scatter within each class. As it only utilizes the labeled data and ignores the unlabeled data in the analysis process of FDA, it cannot be used to solve the unsupervised learning problems. Its performance is also very poor in dealing with semi-supervised learning problems in some cases. Recently, several semi-supervised learning methods as an extension of FDA have proposed. Most of these methods solve the semi-supervised problem by using a tradeoff parameter that evaluates the ratio of the supervised and unsupervised methods. In this paper, we propose a general semi-supervised dimensionality learning idea for the partially labeled data, namely the reconstruction probability class of labeled and unlabeled data. Based on the probability class optimizes Fisher criterion function, we propose a novel Semi-Supervised Local Fisher Discriminant Analysis (S2LFDA) method. Experimental results on real-world datasets demonstrate its effectiveness compared to the existing similar correlation methods.

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Kuehn, Bridget M. "FDA Turns to Electronic “Sentinel” to Flag Prescription Drug Safety Problems." JAMA 300, no. 2 (July 9, 2008): 156. http://dx.doi.org/10.1001/jama.300.2.156.

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Xu, YanJie, ChunYang Wang, Jian Gong, YingJian Zhao, and ChangLin Zhou. "Mainlobe maintenance for FDA-MIMO radar." AIP Advances 12, no. 8 (August 1, 2022): 085305. http://dx.doi.org/10.1063/5.0099177.

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During radar detection, the adaptive beamforming technique needs to create nulls to resist the interference. When the interference appears within the mainlobe, the main detection beam will become distorted. To solve this problem, a new method for the covariance matrix reconstruction is proposed for the mainlobe maintenance problem, and a worst-case performance optimization (WCPO) algorithm with enhanced waveform robustness is obtained. Its integration is performed over a known region without the target information to obtain the improved covariance matrix, which is then brought into the convex optimization equation to solve for the weight vector. Simulation results show that the output signal-to-noise ratio of this algorithm is higher than that of the conventional WCPO algorithm with a robust beam for the same signal-to-noise ratio. It can also effectively eliminate the primary lobe offset and secondary lobe elevation problems.

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Klasmeier, Coleen, and Martin H. Redish. "Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection." American Journal of Law & Medicine 37, no. 2-3 (June 2011): 315–57. http://dx.doi.org/10.1177/009885881103700206.

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In order to protect the nation from harmful or worthless drugs and devices, the Food and Drug Administration (FDA or the Agency) is legislatively authorized to restrict the sale of prescription drugs or medical devices to those whose efficacy and safety have been reviewed and approved by the Agency. Drugs and devices are approved for a specific medical purpose. In numerous instances, however, the medical profession has discovered that treatments approved for one purpose may also serve other valuable medical purposes. Indeed, on a number of occasions such “off-label” treatments have proven to be essential to the successful treatment of some very serious illnesses.In these off-label situations, the FDA is faced with a dilemma. On the one hand, off-label use of prescription drug and devices gives rise to a series of major problems for the FDA. While the drug and devices in question have been vetted and approved by the FDA for their designated purpose, at no point has the FDA reviewed the supporting scientific data to determine efficacy for the off-label purpose.

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Bonet Olivencia, Samuel, and Farzan Sasangohar. "Investigating the Food and Drug Administration Biotherapeutics Review and Approval Process: Narrative Review." JMIR Formative Research 5, no. 3 (March 4, 2021): e14563. http://dx.doi.org/10.2196/14563.

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Background The development, review, and approval process of therapeutic biological products in the United States presents two primary challenges: time and cost. Advancing a biotherapeutic from concept to market may take an average of 12 years, with costs exceeding US $1 billion, and the product may still fail the US Food and Drug Administration (FDA) approval process. Despite the FDA’s practices to expedite the approval of new therapies, seeking FDA approval remains a long, costly, and risky process. Objective The objective of this paper is to explore the factors and gaps related to the FDA review and approval process that contribute to process inefficiencies and complexities as well as proposed methods and solutions to address such gaps. This paper also aims to investigate the available modeling efforts for the FDA approval process of therapeutic biological products. Methods A narrative review of literature was conducted to understand the scope of published knowledge about challenges, opportunities, and specific methods to address the factors and gaps related to the review and approval of new drugs, including therapeutic biological products. Relevant peer-reviewed journal articles, conference proceedings, book chapters, official reports from public policy professional centers, and official reports and guidelines from the FDA were reviewed. Results Of the 23 articles identified in this narrative literature review, none modeled the current FDA review and approval process structure to address issues related to the robustness, reliability, and efficiency of its operations from an external point of view. Although several studies summarize the FDA approval process with clarity, in addition to bringing to light the problems and challenges faced by the regulatory agency, only a few attempts have been made to provide solutions for the problems and challenges identified. In addition, although several reform models have been discussed, these models lack the application of scientific methodologies and modeling techniques in understanding FDA as a complex sociotechnical system. Furthermore, tools and methods to assess the efficacy of the models before implementation are largely absent. Conclusions The findings suggest the efficacy of model-based systems engineering approaches for identifying opportunities for significant improvements to the FDA review and approval process. Using this holistic approach will serve several investigative purposes: identify influential sources of variability that cause major delays, including individual, team, and organizational decision making; identify the human-system bottlenecks; identify areas of opportunity for design-driven improvements; study the effect of induced changes in the system; and assess the robustness of the structure of the FDA approval process in terms of enforcement and information symmetry.

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Karami, Hojat, Mahdi Valikhan Anaraki, Saeed Farzin, and Seyedali Mirjalili. "Flow Direction Algorithm (FDA): A Novel Optimization Approach for Solving Optimization Problems." Computers & Industrial Engineering 156 (June 2021): 107224. http://dx.doi.org/10.1016/j.cie.2021.107224.

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Knopf, Alison. "FDA warns about dental problems with buprenorphine medicines dissolved in the mouth." Brown University Child & Adolescent Psychopharmacology Update 24, no. 3 (February 10, 2022): 8. http://dx.doi.org/10.1002/cpu.30656.

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Marwick, Charles. "FDA Funding Problems Imperil Safety of Biological Products in the United States." JAMA 279, no. 12 (March 25, 1998): 899. http://dx.doi.org/10.1001/jama.279.12.899-jmn0325-2-1.

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E. Aliyeva, Sona. "Problems Regarding Comorbidity of Epilepsy with Depression in Children: A Literature Review." Psychology and Mental Health Care 6, no. 4 (June 4, 2022): 01–04. http://dx.doi.org/10.31579/2637-8892/169.

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Objective: To review the literature on the comorbidity of epilepsy and depression in children. Materials and methods: The following scientific research systems were used to achieve the set goal: MEDLINE; PreMEDLINE; PubMed Central (PMC); Cochrane Library; Scirus. http://www.scirus.com/; Google Scholar; FDA (U.S. Food and Drug Administration); EMA (European Medicines Agency); Rxlist; The New England Journal of Medicine; British Medical Journal; Ovid MD; Best Evidence; UpToDate; Internet Grateful Med; Scientific American Medicine; Clinical Evidence; Harrison’s Online. Results: A search of the Internet and scientific journals revealed 21 sources directly or indirectly related to epilepsy and depression in children. Conclusion: An analysis of the literature has shown that despite the literature on the comorbidity of epilepsy and depression, this problem has not been studied in children. Keywords: children; epilepsy; depression; comorbidity

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Graham, Cynthia A., Petra M. Boynton, and Kate Gould. "Women’s Sexual Desire." European Psychologist 22, no. 1 (January 2017): 27–38. http://dx.doi.org/10.1027/1016-9040/a000282.

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Abstract. Recent changes in the classification of female sexual dysfunction in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM) and the US Food and Drug Administration’s (FDA) approval of the first drug to treat low sexual desire in women (flibanserin) have highlighted the intense focus on sexual desire problems in women. We first discuss the rationale for the DSM changes and outline the DSM-5 criteria for Female Sexual Interest/Arousal Disorder. We provide an overview of some of the key events leading up to the approval of flibanserin for the treatment of hypoactive sexual desire disorder in women, including the role of the “Even the Score” advocacy campaign, that accused the FDA of gender bias in not giving women with sexual desire problems access to treatment options. Incorporating narratives from testimonials of female patients attending the 2014 FDA Patient-Focused Drug Development Public Meeting, we examine some of the prevalent beliefs around sexual “normalcy” and the immutability of sexual desire. We critique how the media and pharmaceutical companies depict sexual norms and female sexual desire and how pharmaceutical trials often narrowly define and assess sexual desire and “sex.” We end with some recommendations for how researchers, clinicians, and journalists can better acknowledge that sex and desire have multiple meanings and interpretations with a view to women being offered a truly informed choice when seeking help for sexual problems.

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Magrabi, Farah, Mei-Sing Ong, William Runciman, and Enrico Coiera. "Using FDA reports to inform a classification for health information technology safety problems." Journal of the American Medical Informatics Association 19, no. 1 (January 2012): 45–53. http://dx.doi.org/10.1136/amiajnl-2011-000369.

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TIMBO, BABGALEH, KATHLEEN M. KOEHLER, CECILIA WOLYNIAK, and KARL C. KLONTZ. "Sulfites—A Food and Drug Administration Review of Recalls and Reported Adverse Events." Journal of Food Protection 67, no. 8 (August 1, 2004): 1806–11. http://dx.doi.org/10.4315/0362-028x-67.8.1806.

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Sulfite-sensitive individuals can experience adverse reactions after consuming foods containing sulfiting agents (sulfites), and some of these reactions may be severe. In the 1980s and 1990s, the U.S. Food and Drug Administration (FDA) acted to reduce the likelihood that sulfite-sensitive individuals would unknowingly consume foods containing sulfites. The FDA prohibited the use of sulfites on fruits and vegetables (except potatoes) to be served or presented fresh to the public and required that the presence of detectable levels of sulfites be declared on food labels, even when these sulfites are used as a processing aid or are a component of another ingredient in the food. In the present study, data from FDA recall records and adverse event reports were used to examine the current status of problems of sensitivity to sulfites in foods. From 1996 through 1999, the FDA processed a total of 59 recalls of foods containing undeclared sulfites; these 59 recalls involved 93 different food products. Fifty (55%) of the recalled products were classified as class I, a designation indicating that a consumer reasonably could have ingested ≥10 mg of undeclared sulfites on a single occasion, a level that could potentially cause a serious adverse reaction in a susceptible person. From 1996 through mid-1999, the FDA received a total of 34 reports of adverse reactions allegedly due to eating foods containing undeclared sulfites. The average of 10 reports per year, although derived from a passive surveillance system, was lower than the average of 111 reports per year that the FDA received from 1980 to 1987, a decrease that may have resulted in part from FDA regulatory action.

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Evans, Barbara J. "The Ethics of Postmarketing Observational Studies of Drug Safety Under Section 505(o)(3) of the Food, Drug, and Cosmetic Act." American Journal of Law & Medicine 38, no. 4 (December 2012): 577–606. http://dx.doi.org/10.1177/009885881203800401.

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In 2007, Congress granted the Food and Drug Administration (FDA) new powers to order pharmaceutical companies to conduct drug safety studies and clinical trials in the postmarketing period after drugs are approved. The methodologies include observational studies that examine patients' insurance claims data and clinical records to infer whether drugs are safe in actual clinical practice. Such studies offer a valuable tool for improving drug safety, but they raise ethical and privacy concerns because they would entail widespread use of patients' health information in commercial research by drug manufacturers. This is the first article to explore the ethics of these section 505(o)(3) observational studies, so named after the section of the Food, Drug, and Cosmetic Act that authorizes them.Data access problems threaten to make the FDA's section 505(o)(3) study requirements unenforceable. Under existing federal privacy regulations, it appears highly unlikely that pharmaceutical companies will have reliable access to crucial data resources, such as insurance claims data and healthcare records, to use in these studies. State privacy laws present another potential barrier to data access. If pharmaceutical companies do manage to gain access to the needed data, this will raise serious privacy concerns because section 505(o)(3) observational studies do not appear to be covered by any of the major federal regulations that afford ethical and privacy protections to persons whose data are used in research.If the FDA's program of section 505(o)(3) observational studies fails because of the above problems, this failure will have a number of bad consequences: the public will be exposed to avoidable drug safety risks; taxpayers may be forced to bear the costs of having the FDA conduct drug safety investigations that would have been funded by drug manufacturers if data had been available; and, perhaps most troubling, the FDA may be forced to order postmarketing clinical trials to answer questions that could have been answered using observational studies. Problems with access to data for section 505(o)(3) studies thus could directly imperil human research subjects by forcing a needless over-reliance on risky postmarketing drug safety trials.This Article concludes by describing a promising new legal pathway for resolving these problems. Congress has provided the FDA a new set of powers that if skillfully exercised will allow the agency: (1) to facilitate pharmaceutical companies' appropriate access to data for use in section 505(o)(3) observational studies, (2) to impose strict ethical and privacy protections for persons whose data are used in these studies, and (3) to mobilize private-sector funding to generate much-needed evidence of the safety of FDA-approved drugs.

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GECAN, JOHN S., and STANLEY M. CICHOWICZ. "Toxic Mushroom Contamination of Wild Mushrooms in Commercial Distribution." Journal of Food Protection 56, no. 8 (August 1, 1993): 730–34. http://dx.doi.org/10.4315/0362-028x-56.8.730.

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Poisonings caused by ingestion of toxic, wild-picked morel mushrooms have been reported to the Food and Drug Administration (FDA). Problems occur when collectors of wild mushrooms inadvertently include toxic look-alike species with the edible wild species offered for sale. A 2-year survey conducted by the FDA showed 21% of the morel and 15% of the wild mixed mushrooms were contaminated with toxic look-alike species. These contaminants contain toxins that produce symptoms ranging from dizziness and gastrointestinal distress to liver and heart damage. Present regulatory controls include FDA Import Alerts for morels contaminated with Gyromitra esculenta and Verpa bohemica, a Michigan state regulation requiring licensing of harvesters of wild mushrooms, and an Illinois state regulation prohibiting the sale of wild-picked mushrooms through retail outlets. American consumers, unable to distinguish between edible and toxic look-alike wild mushrooms, may face illness and possibly death from products purchased on the normally well-regulated U.S. consumer market.

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Bujnak, Alyssa, Carly A. Crowder, and Michael L. Krychman. "Energy-Based Devices for Functional Vaginal Problems: Issues and Answers." Current Sexual Health Reports 13, no. 1 (February 26, 2021): 1–13. http://dx.doi.org/10.1007/s11930-021-00302-x.

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Abstract Vaginal rejuvenation is a marketing term that encompasses surgical and medical treatments for functional vaginal/vulvar problems including but not limited to genitourinary syndrome of menopause (GSM), sexual dysfunction, vaginal laxity, and stress urinary incontinence (SUI) and for esthetic concerns including dissatisfaction with vulvovaginal appearance. Multiple treatment options have become available for indications of functional vaginal problems. Noninvasive management options including the use of more novel treatments such as energy-based devices have gained interest. Previously, studies regarding the efficacy and safety of the energy-based devices for functional vaginal problems were mostly limited to cohort studies without sham treatment, control groups, randomization, or double blinding. As a result of this insufficient data in 2018, the FDA released a statement of warning against the use of energy-based devices in the treatment of functional vaginal problems or vaginal cosmetic procedures (Https://Www.Fda.Gov/Medical-Devices/Safety-Communications/Fda-Warns-Against-Use-Energy-Based-Devices-Perform-Vaginal-Rejuvenation-or-Vaginal-Cosmetic. 1–4, 2018). Purpose of Review This article reviews the most current treatment modalities in the realm of vaginal rejuvenation therapy with an emphasis on the efficacy and safety of the energy-based devices. Recent Findings In the most recent literature, there have been studies with improvements in study design that support the efficacy and the short-term safety of the energy-based devices. Summary More recent studies with improved study design evidence that the use of energy-based devices results in improvements in functional vaginal problems and that serious adverse events appear to be rare. The availability of these devices as treatment options for functional vaginal problems has the potential to impact patient by improving their symptoms and quality of life. Caution still remains however regarding their safety following a longer period of time after their use.

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Wang, Yuzhuo, Shengqi Zhu, Lan Lan, Ximin Li, Zhixin Liu, and Zhixia Wu. "Range-Ambiguous Clutter Suppression via FDA MIMO Planar Array Radar with Compressed Sensing." Remote Sensing 14, no. 8 (April 15, 2022): 1926. http://dx.doi.org/10.3390/rs14081926.

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Range-ambiguous clutter is an inevitable issue for airborne forward-looking array radars, especially with the high pulse repetition frequency (PRF). In this paper, a method to suppress the range-ambiguous clutter is proposed in an FDA-MIMO radar with a forward-looking planar array. Compressed sensing FDA technology is used to suppress the range-ambiguous clutter and the forward-looking non-uniformity short-range clutter of radar. Specifically, first, the range ambiguous clutter in different regions is separated by the characteristics of the planar array radar elevation dimension and FDA radar range coupling. Meanwhile, regarding the issue of the FDA radar main lobe moving between coherent pulses, a main lobe correction (MLC) algorithm proposes a solution for the issue, where the FDA radar cannot coherently accumulate signals in the case of non-full angle illumination. Finally, compressed sensing technology and elevation dimension filtering are utilized to suppress the range ambiguous clutter at the receiver, with the approach alleviating the range dependence of clutter in the observation region. A small number of clutter snapshots can obtain an approximately ideal clutter covariance matrix through compressed sensing sparse recovery. The method not only reduces the number of training samples, but also overcomes the problem of clutter non-uniformity in the forward-looking array. Therefore, the clutter suppression problems faced by the high repetition frequency airborne radar forward-looking array structure are solved. At the analysis stage, a comparison among the conventional MIMO and FDA methods is carried on by analyzing the improvement factor (IF) curves. Numerical results verify the effectiveness of the proposed method in range-ambiguous clutter suppression.

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Bayless, William C. "LATE PUBLICATION OF PRODUCT RECALLS BY FDA CAN CAUSE PROBLEMS FOR MANUFACTURERS AND HOSPITALS." Biomedical Safety & Standards 15, no. 12 (June 1985): 94. http://dx.doi.org/10.1097/00149078-198506150-00010.

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Marwick, Charles. "Nontherapeutic Problems of Generic Drugs Lead to Call for FDA, Legislative Diagnosis and Cure." JAMA: The Journal of the American Medical Association 262, no. 12 (September 22, 1989): 1566. http://dx.doi.org/10.1001/jama.1989.03430120016004.

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Marwick, C. "Nontherapeutic problems of generic drugs lead to call for FDA, legislative diagnosis and cure." JAMA: The Journal of the American Medical Association 262, no. 12 (September 22, 1989): 1566–67. http://dx.doi.org/10.1001/jama.262.12.1566.

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Dempsey, James J., and Mark Ross. "Evaluation of Hardwire Personal Assistive Listening Devices." American Journal of Audiology 3, no. 2 (July 1994): 71–77. http://dx.doi.org/10.1044/1059-0889.0301.71.

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A large number of personal amplifiers have recently become available commercially. These devices have not been classified as hearing aids by the FDA and are therefore not subject to the FDA rules and regulations governing the sales of hearing aid devices. In this investigation, several of these personal amplifiers were evaluated to determine potential benefits and problems for each device. The devices were evaluated electroacoustically and, also, subjectively by a group of adults with sensorineural hearing loss. The results of the electroacoustic evaluation revealed very sharply peaked frequency responses. The subjective evaluations revealed tremendous variability, with some preferences for power and low-frequency amplification. Clinical implications of these results and suggestions for further research are provided.

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Abramson, Norman, Alan Meisel, and Peter Safar. "Ethical and Legal Problems in Resuscitation Research." Prehospital and Disaster Medicine 1, S1 (1985): 59–60. http://dx.doi.org/10.1017/s1049023x00043788.

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Medicine has made great advances in the past decade, and is now opening the frontiers of brain resuscitation. Coinciding with the advances in medicine, society has witnessed great changes. There is an increasing awareness of patients' rights, an increasing desire for self determination, a rejection of the once-accepted paternal role of the physician, and an increasing willingness to challenge physicians in the courts. At the same time, government regulation of biomedical research has been expanding rapidly. The origin of this regulation dates back to the post-World War II Nuremburg trials. In 1974, the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The evolving concern about human experimentation has led to the current Department of Health and Human Services (DHHS) and the Federal Drug Administration (FDA) regulations which became effective July 27,1981. All biomedical research supported by federal funds must conform to these legal requirements. One aspect of these regulations is that all research protocols be approved by an institutional review board (IRB) established at the institution where the research is conducted.

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Thomas, W. John. "The Vioxx Story: Would it Have Ended Differently in the European Union?" American Journal of Law & Medicine 32, no. 2-3 (June 2006): 365–80. http://dx.doi.org/10.1177/009885880603200210.

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The rise and fall of the pain-killer Vioxx is one of the most remarkable marketing stories in pharmaceutical history. A true riches to rags tale, its events unfolded with lightning speed in an industry defined by lethargy.On May 20, 1999, the Merck Company secured FDA approval of Vioxx for the management of acute pain in adults and for relief of the signs and symptoms of osteoarthritis. From that date through August 2004, 105 million Vioxx prescriptions were filled in the US and an undetermined number were filled outside the US. In 2003 alone, Merck's worldwide Vioxx sales totaled $2.5 billion.The fall happened even more quickly than the rise. In March 2000, Merck published a study raising the specter of cardiovascular problems associated with taking Vioxx. In November 2000, The New England Journal of Medicine published a study raising similar concerns. In February 2001, an FDA advisory panel became sufficiently concerned about the association of Vioxx and cardiovascular events that it advised the FDA to require a label warning about the possible link.

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Hino, Hideitsu, and Noboru Murata. "A Conditional Entropy Minimization Criterion for Dimensionality Reduction and Multiple Kernel Learning." Neural Computation 22, no. 11 (November 2010): 2887–923. http://dx.doi.org/10.1162/neco_a_00027.

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Reducing the dimensionality of high-dimensional data without losing its essential information is an important task in information processing. When class labels of training data are available, Fisher discriminant analysis (FDA) has been widely used. However, the optimality of FDA is guaranteed only in a very restricted ideal circumstance, and it is often observed that FDA does not provide a good classification surface for many real problems. This letter treats the problem of supervised dimensionality reduction from the viewpoint of information theory and proposes a framework of dimensionality reduction based on class-conditional entropy minimization. The proposed linear dimensionality-reduction technique is validated both theoretically and experimentally. Then, through kernel Fisher discriminant analysis (KFDA), the multiple kernel learning problem is treated in the proposed framework, and a novel algorithm, which iteratively optimizes the parameters of the classification function and kernel combination coefficients, is proposed. The algorithm is experimentally shown to be comparable to or outperforms KFDA for large-scale benchmark data sets, and comparable to other multiple kernel learning techniques on the yeast protein function annotation task.

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Lu, Kevin, and Patricia Slattum. "USING REAL-WORLD EVIDENCE TO SUPPORT THE FDA REGULATORY APPROVAL: METHODOLOGICAL CONSIDERATIONS." Innovation in Aging 6, Supplement_1 (November 1, 2022): 193. http://dx.doi.org/10.1093/geroni/igac059.770.

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Abstract Evidence from clinical trials has traditionally been used to support regulatory drug approval, whereas real-world evidence (RWE) has been used for post-marketing surveillance studies. With the enaction of the 21st Century Cures Act, the Food and Drug Administration (FDA) is evaluating the potential use of RWE to support new indications for an approved product or to satisfy post-approval study requirements. Yet the substantial evidence standard remains unchanged for FDA approval. To date, the FDA has issued guidelines or frameworks for using RWE for regulatory decisions. However, many methodological challenges remain unanswered when using RWE in gerontology research. This Pharmaceutical Care and Outcomes Research Interest Group-sponsored symposium consists of leading experts in the country to address these problems. The four papers in this symposium will address methodological challenges that are unique in gerontology research. Specifically, The first paper will introduce the FDA drug evaluation process, focusing on the key considerations for evaluating RWE in regulatory decision making; the second paper will discuss possible challenges related to data sources from which RWE are generated in aging research; the third paper will provide a case example of some of the challenges in using RWD sources to generate RWE in the Alzheimer’s Disease setting; and the fourth paper will provide recommendations for improving gerontology research based on RWE going forward.

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Shuster, Joel. "ADRs Causing Hospital Admissions; A Reader's Tale of Serotonin Syndrome; Adverse Effects of Laxatives; Oxcarbazepine-Induced SIADH; Two Problems with Fluoroquinolones." Hospital Pharmacy 37, no. 11 (November 2002): 1143–46. http://dx.doi.org/10.1177/001857870203701109.

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The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.

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Sun, Chunlei, Xi Rong, Yongqin Cai, Song Qiu, and Maryam Farzaneh. "Mini review: The FDA‐approved prescription drugs that induce ovulation in women with ovulatory problems." Drug Development Research 81, no. 7 (May 19, 2020): 815–22. http://dx.doi.org/10.1002/ddr.21687.

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VENUGOPAL, RAJESH, LINDA TOLLEFSON, FREDERICK N. HYMAN, BAB TIMBO, RONALD E. JOYCE, and KARL C. KLONTZ. "Recalls of Foods and Cosmetics by the U.S. Food and Drug Administration." Journal of Food Protection 59, no. 8 (August 1, 1996): 876–80. http://dx.doi.org/10.4315/0362-028x-59.8.876.

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Recalls of foods and cosmetics from the marketplace are an expeditious and effective method of removing violative products, particularly those that present a danger to health. Recalls are undertaken through a cooperative effort by industry and the U.S. Food and Drug Administration (FDA). Foods and cosmetics recalled from the period 1 October 1991 through 30 September 1992 were reviewed to determine the kinds of products recalled and the reasons for recall. A total of 230 recalls, involving 569 foods and cosmetics, occurred during the study period. Twenty-eight percent of the recalls were designated class I, defined as a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences. The problems for which foods or cosmetics were most often recalled were misbranding and microbial contamination (37% and 25% of recalls, respectively). A recognized illness or injury was reported to have occurred in association with 32 food products and one cosmetic. This study indicates that recalls of foods and cosmetics are common and that various groups, including industry, consumers, state regulatory agencies, and the FDA, recognize problems leading to recall.

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Wallin, Richard F. "Current Problems in Devices Evaluation: Some Solutions." Journal of the American College of Toxicology 7, no. 4 (July 1988): 491–97. http://dx.doi.org/10.3109/10915818809019522.

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Medical devices and their component materials are potential sources of toxins that may produce undesirable local or systemic effects when used clinically. Federal regulations thus require manufacturers to establish the safety of their products. Until 1987, FDA provided few specific guidelines for testing medical devices, although many standardized testing methods had been placed in use by industry. Now, proposed guidelines exist, but device manufacturers still face significant problems that are similar to those encountered when testing drugs and chemicals: (1) a strategy for testing must be established to make best use of screening methods, to develop parallel information about various families of products, and to make best use of resources, (2) test articles must be selected to represent finished products, not prototype formulations, (3) sample preparation must be appropriate and relate to product use conditions, (4) test methods that are inappropriate based on end use of a product must be avoided, (5) all potential sources of toxins must be taken into account, including raw materials, processing and manufacturing aids, and sterilization processes, and (6) Good Laboratory Practices must receive appropriate attention. In vitro alternatives to animal test methods are used widely for primary evaluation of biocompatibility, but suitable animal models are not yet available for preclinical evaluation of some devices.

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Dreyfus, J. F., D. Cremniter, and J. D. Guelfi. "Reflections on FDA and WHO recommendations concerning clinical trials." Psychiatry and Psychobiology 4, no. 2 (1989): 117–22. http://dx.doi.org/10.1017/s0767399x00002960.

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SummaryWe are still confronted by numerous different nosographic models and problems concerning the objective evaluation of patients progress during treatment. It is interesting to consider the consequences of this situation in psychiatry which still involves a relative diversity of practical methods used in clinical trials. The recommendations of the USA Food and Drug Administration, on the one hand, constitute a highly structured and precise reference. The World Health Organization, on the other hand, promulgates general recommendations resulting from a compromise designed to satisfy the greatest number of clinicians.Despite the apparently diverse principles and the different practical methods they propose, both those sets of recommendations have been useful in inspiring clinicians to reflect upon these different methodological approaches. The qualities of the inclusion criteria used in the study of patients and the sensitivity of the different measuring instruments have allowed psychotropic drug users as well as producers to recognize the need for a certain rigour in clinical trials.The FDA and WHO guidelines have certainly improved the quality of clinical trials in psychopharmacology. However, they also represent a source of resistance to innovation.A series of consensus meetings to first reconcile US and European points of view and later to include new techniques in the recognized sets of methods would therefore be helpful.

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Nikoobin, A., and M. Moradi. "Indirect solution of optimal control problems with state variable inequality constraints: finite difference approximation." Robotica 35, no. 1 (July 2, 2015): 50–72. http://dx.doi.org/10.1017/s0263574715000521.

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SUMMARYIn this paper, a method for the indirect solution of the optimal control problem (OCP) in the presence of pure state variable inequality constraints (SVICs) and mixed state-control inequality constraints (SCIC), without a need for a close initial guess is presented. In the proposed method, using the finite difference approximation (FDA), the pure SVICs are converted to SCIC. Here, the distance of the constraint function to the feasibility bounds of the constraint is computed in every situation and the control signal is chosen appropriately to facilitate the constraint stays safe. In this method, prior knowledge of the numbers and sequences of activation times is not required. So, it can be simply implemented in continuous boundary value problem (BVP) solvers. The proposed method simply applies the SVICs and since the constraint is directly applied on the control signal, it improves the convergence. On the other hand, because of the convergence problem in the indirect solution of OCP, the simple homotopy continuation method (HCM) is used to overcome the initial guess problem by deploying a secondary OCP for which the initial guess can be zero. The proposed approach is applied on a few comprehensive problems in the presence of different constraints. Simulations are compared with the direct solution of the OCP to confirm the accuracy and with the penalty function method and the sequential constraint-free OCP to confirm the convergence. The results indicate that the FDA method for handling the constraints along with the HCM is easy to apply with acceptable accuracy and convergence, even for highly nonlinear problems in robotic systems such as the constrained time optimal control of a two-link manipulator (TLM) and a three-link common industrial robot.

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Azevedo, Leonardo. "Model reduction in geostatistical seismic inversion with functional data analysis." GEOPHYSICS 87, no. 1 (November 10, 2021): M1—M11. http://dx.doi.org/10.1190/geo2021-0096.1.

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In subsurface modeling and characterization, predicting the spatial distribution of subsurface elastic properties is commonly achieved by seismic inversion. Stochastic seismic inversion methods, such as iterative geostatistical seismic inversion (GSI), are widely applied to this end. Global iterative GSI methods are computationally expensive because they require, at a given iteration, the stochastic sequential simulation of the entire inversion grid at once multiple times. Functional data analysis (FDA) is a well-established statistical method suited to model long-term and noisy temporal series. This method allows us to summarize spatiotemporal series in a set of analytical functions with a low-dimension representation. FDA has been recently extended to problems related to geosciences, but its application to geophysics is still limited. We have developed the use of FDA as a model reduction technique during the model perturbation step in global iterative GSI. FDA is used to collapse the vertical dimension of the inversion grid. We illustrate our hybrid inversion method with its application to 3D synthetic and real data sets. The results indicate the ability of our inversion methodology to predict smooth inverted subsurface models that match the observed data at a similar convergence as obtained by a global iterative GSI, but with a considerable decrease in the computational cost. Although the resolution of the inverted models might not be enough for a detailed subsurface characterization, the inverted models can be used as a starting point of global iterative GSI to speed up the inversion or to test alternative geologic scenarios by changing the inversion parameterization and obtaining inverted models in a relatively short time.

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Meléndez, Rafael, Ramón Giraldo, and Víctor Leiva. "Sign, Wilcoxon and Mann-Whitney Tests for Functional Data: An Approach Based on Random Projections." Mathematics 9, no. 1 (December 28, 2020): 44. http://dx.doi.org/10.3390/math9010044.

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Sign, Wilcoxon and Mann-Whitney tests are nonparametric methods in one or two-sample problems. The nonparametric methods are alternatives used for testing hypothesis when the standard methods based on the Gaussianity assumption are not suitable to be applied. Recently, the functional data analysis (FDA) has gained relevance in statistical modeling. In FDA, each observation is a curve or function which usually is a realization of a stochastic process. In the literature of FDA, several methods have been proposed for testing hypothesis with samples coming from Gaussian processes. However, when this assumption is not realistic, it is necessary to utilize other approaches. Clustering and regression methods, among others, for non-Gaussian functional data have been proposed recently. In this paper, we propose extensions of the sign, Wilcoxon and Mann-Whitney tests to the functional data context as methods for testing hypothesis when we have one or two samples of non-Gaussian functional data. We use random projections to transform the functional problem into a scalar one, and then we proceed as in the standard case. Based on a simulation study, we show that the proposed tests have a good performance. We illustrate the methodology by applying it to a real data set.

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Journal articles on the topic 'FDA problems'

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