Journal articles: 'FOOD AND DRUGS ADMINISTRATION'

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Hutcheon, Duncan E. "Drugs Approved by Food & Drug Administration." Journal of Clinical Pharmacology 29, no. 5 (May 1989): 478–79. http://dx.doi.org/10.1002/j.1552-4604.1989.tb03366.x.

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Furlan, Anthony J., and Marc Fisher. "Devices, Drugs, and the Food and Drug Administration." Stroke 36, no. 2 (February 2005): 398–99. http://dx.doi.org/10.1161/01.str.0000153057.07181.94.

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Tsimberidou, Apostolia-Maria, Fadi Braiteh, David J. Stewart, and Razelle Kurzrock. "Ultimate Fate of Oncology Drugs Approved by the US Food and Drug Administration Without a Randomized Trial." Journal of Clinical Oncology 27, no. 36 (December 20, 2009): 6243–50. http://dx.doi.org/10.1200/jco.2009.23.6018.

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Purpose To approve a new anticancer drug, the US Food and Drug Administration often requires randomized trials. However, several oncology drugs have been approved on the basis of objective end points without a randomized trial. We reviewed the long-term safety and efficacy of such agents. Methods We searched the Web site of the US Food and Drug Administration's Center for Drug Evaluation and Research and MEDLINE for initial applications of investigational anticancer drugs from 1973 through 2006. Results Overall, 68 oncology drugs, excluding hormone therapy and supportive care, were approved, including 31 without a randomized trial. For these 31 drugs, a median of two clinical trials (range, one to seven) and 79 patients (range, 40 to 413) were used per approval. Objective response was the most common end point used for approval; median response rate was 33% (range, 11% to 90%). Thirty drugs are still fully approved. United States marketing authorization for one drug, gefitinib (an epidermal growth factor receptor [EGFR] inhibitor), was rescinded after a randomized trial showed no survival improvement; however, this trial was performed in unselected patients, and it was subsequently demonstrated that patients with EGFR mutation are more likely to respond. Nineteen of the 31 drugs have additional uses (per National Comprehensive Cancer Network or National Cancer Institute Physician Data Query guidelines), and subsequent formal US Food and Drug Administration approvals were obtained for 11 of these (range, one to 18 new indications). No drug has demonstrated safety concerns. Conclusion Nonrandomized clinical trials with definitive end points can yield US Food and Drug Administration approvals, and these drugs have a reassuring record of long-term safety and efficacy.

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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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Rangaraj, Nagarjun, Sunitha Sampathi, Vijayabhaskarreddy Junnuthula, Praveen Kolimi, Preethi Mandati, Sagar Narala, Dinesh Nyavanandi, and Sathish Dyawanapelly. "Fast-Fed Variability: Insights into Drug Delivery, Molecular Manifestations, and Regulatory Aspects." Pharmaceutics 14, no. 9 (August 27, 2022): 1807. http://dx.doi.org/10.3390/pharmaceutics14091807.

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Among various drug administration routes, oral drug delivery is preferred and is considered patient-friendly; hence, most of the marketed drugs are available as conventional tablets or capsules. In such cases, the administration of drugs with or without food has tremendous importance on the bioavailability of the drugs. The presence of food may increase (positive effect) or decrease (negative effect) the bioavailability of the drug. Such a positive or negative effect is undesirable since it makes dosage estimation difficult in several diseases. This may lead to an increased propensity for adverse effects of drugs when a positive food effect is perceived. However, a negative food effect may lead to therapeutic insufficiency for patients suffering from life-threatening disorders. This review emphasizes the causes of food effects, formulation strategies to overcome the fast-fed variability, and the regulatory aspects of drugs with food effects, which may open new avenues for researchers to design products that may help to eliminate fast-fed variability.

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Kharitonovа, L. A., A. M. Zaprudnov, and K. I. Grigoriev. "Mandatory assessment of trophological status and nutrition in children in drugs prescribing." Experimental and Clinical Gastroenterology, no. 1 (May 2, 2020): 4–14. http://dx.doi.org/10.31146/1682-8658-ecg-173-1-4-14.

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The article discusses interactions between medications (Ms) and food. The influence of Ms on the processes of absorption of the essential food ingredients, vitamins, macro- and trace elements in the gastrointestinal tract is analyzed. The significance of the malabsorption syndrome, antibiotic-associated diarrhea as cause of the impaired nutritional status is emphasized. Simultaneously, food products are able of altering the pharmacological effect of some most common drugs. Administration of Ms depending on food intake is discussed. The importance of taking into consideration the influence of foods and theirbiologically active substances on the pharmacokinetics of Ms in the body is pointed out.

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Sharma, Ajitha, and Rathnakar Up. "REVISED FOOD AND DRUG ADMINISTRATION RISK CATEGORIES OF DRUGS DURING PREGNANCY." Asian Journal of Pharmaceutical and Clinical Research 10, no. 7 (July 1, 2017): 77. http://dx.doi.org/10.22159/ajpcr.2017.v10i7.16539.

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Butler, O. D., Woodrow M. Knight, and Jack C. Taylor. "The Regulation of Production Drugs by the Food and Drug Administration." Professional Animal Scientist 2, no. 1 (June 1986): 14–17. http://dx.doi.org/10.15232/s1080-7446(15)32415-3.

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Blankfield, Robert P., and Imran H. Iftikhar. "Food and Drug Administration Regulation of Drugs That Raise Blood Pressure." Journal of Cardiovascular Pharmacology and Therapeutics 20, no. 1 (May 6, 2014): 5–8. http://dx.doi.org/10.1177/1074248414531852.

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Ashley, Donald D. "Clarifying Misconceptions About US Food and Drug Administration Unapproved Drugs Program." Anesthesia & Analgesia 127, no. 6 (December 2018): 1292–94. http://dx.doi.org/10.1213/ane.0000000000003852.

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Sukhatme, Vidula V., Suresh S. Ramalingam, Rafi Ahmed, and Vikas P. Sukhatme. "Repurposing Food and Drug Administration–Approved Drugs to Promote Antitumor Immunity." Cancer Journal 25, no. 2 (2019): 88–99. http://dx.doi.org/10.1097/ppo.0000000000000368.

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Ofosu, Frederick A. "The United States Food and Drugs Administration Approves a Generic Enoxaparin." Clinical and Applied Thrombosis/Hemostasis 17, no. 1 (December 15, 2010): 5–8. http://dx.doi.org/10.1177/1076029610389028.

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Yao, Hsien-Tsung, Jia-Hsuan Lin, Yun-Ta Liu, Mei-Ling Li, and Wenchang Chiang. "Food–Drug Interaction between the Adlay Bran Oil and Drugs in Rats." Nutrients 11, no. 10 (October 15, 2019): 2473. http://dx.doi.org/10.3390/nu11102473.

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Adlay (Coix lachryma-jobi L. var. ma-yuen Stapf) contains various phytonutrients for treating many diseases in Asia. To investigate whether orally administered adlay bran oil (ABO) can cause drug interactions, the effects of ABO on the pharmacokinetics of five cytochrome P450 (CYP) probe drugs were evaluated. Rats were given a single oral dose (2.5 mL/kg BW) of ABO 1 h before administration of a drug cocktail either orally or intravenously, and blood was collected at various time points. A single oral dose of ABO administration did not affect the pharmacokinetics of five probe drugs when given as a drug cocktail intravenously. However, ABO increased plasma theophylline (+28.4%), dextromethorphan (+48.7%), and diltiazem (+46.7%) when co-administered an oral drug cocktail. After 7 days of feeding with an ABO-containing diet, plasma concentrations of theophylline (+45.4%) and chlorzoxazone (+53.6%) were increased after the oral administration of the drug cocktail. The major CYP enzyme activities in the liver and intestinal tract were not affected by ABO treatment. Results from this study indicate that a single oral dose or short-term administration of ABO may increase plasma drug concentrations when ABO is given concomitantly with drugs. ABO is likely to enhance intestinal drug absorption. Therefore, caution is needed to avoid food–drug interactions between ABO and co-administered drugs.

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Tao, Rachel E., Stuti Prajapati, Jessica N. Pixley, Ayman Grada, and Steven R. Feldman. "Oral Tetracycline-Class Drugs in Dermatology: Impact of Food Intake on Absorption and Efficacy." Antibiotics 12, no. 7 (July 5, 2023): 1152. http://dx.doi.org/10.3390/antibiotics12071152.

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Tetracycline-class drugs are frequently used in dermatology for their anti-inflammatory properties to treat skin diseases such as acne, rosacea, and hidradenitis suppurativa (HS). The American Academy of Dermatology (AAD) clinical guidelines do not offer guidance regarding the co-administration of food with tetracycline-class drugs. The objectives of this study were to review the available evidence regarding whether taking tetracycline-class drugs with food decreases systemic absorption and is associated with an impact on clinical efficacy. A literature search was conducted using the PubMed database between February to May 2023 using the keywords “tetracycline-class drugs”, “pharmacokinetics”, “absorption”, and “dermatology”. Inclusion criteria included articles written in English and relevant to the absorption and efficacy of tetracycline-class drugs. This search yielded 131 articles written between 1977 to 2022, of which 29 met the criteria for review. United States Food and Drug Administration (FDA)-approved prescribing information for oral formulations of tetracycline, doxycycline, minocycline, and sarecycline were reviewed. Systemic absorption of tetracycline decreased when co-administered with food. Systemic absorption of oral doxycycline and minocycline was variable with food co-administration. The impact on bioavailability varied with the drug formulation and dosage. The absorption of oral sarecycline decreased when administered with food. Sarecycline is the only oral antibiotic where population pharmacokinetic studies demonstrated limited or no impact of food intake on clinical efficacy. There are no available data for other tetracycline-class drugs in dermatology. If patients find it more tolerable to take doxycycline, minocycline, and sarecycline with food to avoid gastrointestinal distress, this may merit consideration to encourage patient adherence. Since the impact of food intake on absorption varied with the dosage form of doxycycline and minocycline, consulting the appropriate package insert may give clinicians additional insight into differences in the various formulations.

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S, Shidhaye. "Effect of Food on Bioavailability of Drug through Gastro-Retentive Drug Delivery System." Bioequivalence & Bioavailability International Journal 5, no. 1 (2021): 1–3. http://dx.doi.org/10.23880/beba-16000148.

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Gastro retentive drug delivery systems (GRDDS) have been explored for controlling the release of the drugs by oral administration. However, since these systems are intended to reside in the gastric region for longer period of time, several factors are expected to hamper the absorption rates of the drug in GRDDS. These systems are in contact with the gastric content for longer time and thus, “Food” is expected to interfere with the rate of absorption from these systems. This article focuses on various foods related factors responsible for affecting absorption from the GRDDS type of novel system.

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Lloyd, Rhea, Jennifer Harris, Sonal Wadhwa, and Wiley Chambers. "Food and Drug Administration approval process for ophthalmic drugs in the US." Current Opinion in Ophthalmology 19, no. 3 (May 2008): 190–94. http://dx.doi.org/10.1097/icu.0b013e3282f97fa1.

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de La Garza, René, and Chris E. Johanson. "The effects of food deprivation on the self-administration of psychoactive drugs." Drug and Alcohol Dependence 19, no. 1 (January 1987): 17–27. http://dx.doi.org/10.1016/0376-8716(87)90083-4.

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Nasr, Alexander, Thomas J. Lauterio, and Matthew W. Davis. "Unapproved drugs in the united states and the food and drug administration." Advances in Therapy 28, no. 10 (September 1, 2011): 842–56. http://dx.doi.org/10.1007/s12325-011-0059-4.

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Hwang, Thomas J., Jessica M. Franklin, Christopher T. Chen, Julie C. Lauffenburger, Bishal Gyawali, Aaron S. Kesselheim, and Jonathan J. Darrow. "Efficacy, Safety, and Regulatory Approval of Food and Drug Administration–Designated Breakthrough and Nonbreakthrough Cancer Medicines." Journal of Clinical Oncology 36, no. 18 (June 20, 2018): 1805–12. http://dx.doi.org/10.1200/jco.2017.77.1592.

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Purpose The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. We evaluated the times to approval, efficacy, and safety of breakthrough-designated versus non–breakthrough-designated cancer drugs approved by the US Food and Drug Administration (FDA). Methods We studied all new cancer drugs approved by the FDA between January 2012 and December 2017. Regulatory and therapeutic characteristics (time to FDA approval, pivotal trial efficacy end point, novelty of mechanism of action) were compared between breakthrough-designated and non–breakthrough-designated cancer drugs. Random-effects meta-regression was used to assess the association between breakthrough therapy designation and hazard ratios for progression-free survival (PFS), response rates (RRs) for solid tumors, serious adverse events, and deaths not attributed to disease progression. Results Between 2012 and 2017, the FDA approved 58 new cancer drugs, 25 (43%) of which received breakthrough therapy designation. The median time to first FDA approval was 5.2 years for breakthrough-designated drugs versus 7.1 years for non–breakthrough-designated drugs (difference, 1.9 years; P = .01). There were no statistically significant differences between breakthrough-designated and non–breakthrough-designated drugs in median PFS gains (8.6 v 4.0 months; P = .11), hazard ratios for PFS (0.43 v 0.51; P = .28), or RRs for solid tumors (37% v 39%; P = .74). Breakthrough therapy–designated drugs were not more likely to act via a novel mechanism of action (36% v 39%; P = 1.00). Rates of deaths (6% v 4%; P = .99) and serious adverse events (38% v 36%; P = 0.93) were also similar in breakthrough-designated and non–breakthrough-designated drugs. Conclusion Breakthrough-designated cancer drugs were associated with faster times to approval, but there was no evidence that these drugs provide improvements in safety or novelty; nor was there a statistically significant efficacy advantage when compared with non–breakthrough-designated drugs.

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Kaplan, Robert M., Amanda J. Koong, and Veronica Irvin. "Review of Evidence Supporting 2022 US Food and Drug Administration Drug Approvals." JAMA Network Open 6, no. 8 (August 8, 2023): e2327650. http://dx.doi.org/10.1001/jamanetworkopen.2023.27650.

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Ward, Robert M. "Children, Drugs, and the Food and Drug Administration: Studies of Pediatric Drugs Are Beginning to Catch Up." Pediatric Annals 30, no. 4 (April 1, 2001): 189–94. http://dx.doi.org/10.3928/0090-4481-20010401-06.

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Tibau, Ariadna, Alberto Ocana, Geòrgia Anguera, Bostjan Seruga, Arnoud J. Templeton, Agustí Barnadas, and Eitan Amir. "Oncologic Drugs Advisory Committee Recommendations and Approval of Cancer Drugs by the US Food and Drug Administration." JAMA Oncology 2, no. 6 (June 1, 2016): 744. http://dx.doi.org/10.1001/jamaoncol.2015.6479.

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Molto, Consolacion, Thomas J. Hwang, Marta Andres, Maria Borrell, Ignasi J. Gich Saladich, Agust Barnadas, Eitan Amir, Aaron S. Kesselheim, and Ariadna Tibau Martorell. "Clinical benefit of breakthrough cancer drugs approved by the United States Food and Drug Administration." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): 6513. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.6513.

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6513 Background: The Breakthrough Therapy program was established in July 2012 to expedite drug development and approval by the FDA. We compared the characteristics of clinical trials leading to FDA approval as well as the magnitude of clinical benefit and value framework scores of breakthrough-designated and non-breakthrough-designated cancer drugs. Methods: We searched the Drugs@FDA website for cancer drug approvals from July 2012 and December 2017. For each indication, we applied the value frameworks and used thresholds of high clinical benefit developed by American Society of Clinical Oncology Value Framework version 2 (ASCO VF v2; scores ≥45), the ASCO Cancer Research Committee (OS gains ≥2.5 months PFS gains ≥3 months), the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1; grade of A or B for trials of curative intent and 4 or 5 for those of non-curative intent), and the National Comprehensive Cancer Network (NCCN) Evidence Blocks (scores of 4 and 5). Trial characteristics and value framework scores were compared using Chi squared or Mann Whitney U tests. Results: We identified 106 pivotal trials supporting the approval of 52 individual drugs for 96 indications. Of these indications, 38 (40%) received breakthrough designation. Compared with trials for non-breakthrough drugs (n = 62), trials for breakthrough drugs (n = 44) had smaller sample size (median 373 vs 612, P= .03), were less often randomized (57% vs 86%; P= .001) and more likely to be open-label (84% vs 53%, P= .001). Trials for breakthrough drugs were more likely to demonstrate high clinical benefit using ASCO VF (68% vs 31%, P= .002) and NCCN Evidence Blocks (86% vs 56%, P= .002). A similar proportion of trials supporting breakthrough and non-breakthrough drugs demonstrated high clinical benefit using the ASCO Cancer Research Committee (82% vs 68%, P= .25) and ESMO-MCBS (35% vs 33%; P= .87) frameworks. Conclusions: In patients with advanced solid tumors, cancer drugs approved under breakthrough therapy designation were more likely to demonstrate high clinical benefit as defined by the ASCO VF and NCCN value frameworks. A similar proportion of approved breakthrough and non-breakthrough therapy drugs met the high benefit thresholds using the ASCO Cancer Research Committee and ESMO-MCBS frameworks.

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Kayki-Mutlu, Gizem, and Martin C. Michel. "A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2020." Naunyn-Schmiedeberg's Archives of Pharmacology 394, no. 5 (April 16, 2021): 839–52. http://dx.doi.org/10.1007/s00210-021-02085-3.

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AbstractWhile the COVID-19 pandemic also affected the work of regulatory authorities, the US Food and Drug Administration approved a total of 53 new drugs in 2020, one of the highest numbers in the past decades. Most newly approved drugs related to oncology (34%) and neurology (15%). We discuss these new drugs by level of innovation they provide, i.e., first to treat a condition, first using a novel mechanisms of action, and “others.” Six drugs were first in indication, 15 first using a novel mechanism of action, and 32 other. This includes many drugs for the treatment of orphan indications and some for the treatment of tropical diseases previously neglected for commercial reasons. Small molecules continue to dominate new drug approvals, followed by antibodies. Of note, newly approved drugs also included small-interfering RNAs and antisense oligonucleotides. These data show that the trend for declines in drug discovery and development has clearly been broken.

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Aebersold, Paul. "FDA Experience with Medical Countermeasures under the Animal Rule." Advances in Preventive Medicine 2012 (2012): 1–11. http://dx.doi.org/10.1155/2012/507571.

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The Food and Drug Administration issued a final rule in May 2002 to permit the Agency to approve drugs or license biological products on the basis of animal efficacy studies for use in ameliorating or preventing serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic biological, chemical, radiological, or nuclear substances. Only two drugs were approved in the first nine years of the “Animal Rule” despite massive investment by the federal government since 2001 to stimulate development of medical countermeasures to biological threats. This article therefore examines the Food and Drug Administration reviews made public after approval of those two drugs and the public discussion at the Agency's Anti-Infective Drugs Advisory Committee of one biological product under development under the Animal Rule. Despite the paucity of approved drugs or licensed biological products as medical countermeasures, several investigational drugs have been placed in the National Strategic Stockpile for use as medical countermeasures, if needed.

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Basin, Bhawna. "New Drugs for Breast Cancer Treatment." TEXILA INTERNATIONAL JOURNAL OF ACADEMIC RESEARCH 10, no. 3 (July 28, 2023): 26–33. http://dx.doi.org/10.21522/tijar.2014.10.03.art003.

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Breast cancer is the most common type of cancer in women, affecting approximately 12% of women over the course of their lifetime. It was estimated that there would be 81,550 new cases of invasive breast cancer in women in the United States (US), along with 49,290 new cases of non-invasive breast cancer. A search was conducted to find out the number of new breast cancer drugs that have been approved by US Food and Drug Administration (FDA) in the last 2 years (2020 2021), and the number of breast cancer drugs that are currently under Phase 3 clinical trials. Between 2020 and 2021, 4 new drugs have been approved by FDA for the treatment of breast cancer: Tukysa (Seagen), Margenza (MacroGenics), Phesgo (Genentech), and Trodelvy (Gilead Sciences). Research continues to find out new drugs that can help treat breast cancer. Currently, there are several breast cancer treatment drugs in Phase 3 clinical trials including two major new breast cancer drugs Palbociclib (Pfizer) and Ribociclib (Novartis). Pharmaceutical and biotech companies are making incredible contributions by developing many innovative and effective treatments for breast cancers. We are hopeful that many new breast cancer drugs will be approved in the coming years. Keywords: Breast cancer, Food and Drug Administration(FDA), New Drugs, Clinical Trials.

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Chhim, Rebecca F., Chasity M. Shelton, and Michael L. Christensen. "Recent New Drug Approvals, Part 2: Drugs Undergoing Active Clinical Studies in Children." Journal of Pediatric Pharmacology and Therapeutics 18, no. 1 (January 1, 2013): 14–38. http://dx.doi.org/10.5863/1551-6776-18.1.14.

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The objective of this 2-part review is to provide information about drugs that have been recently approved by the US Food and Drug Administration. Part 1 reviewed recently approved drugs with pediatric indications. Part 2 reviews drugs recently approved only in adults and have published or ongoing studies in children.

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Ayele, Yohanes, Abraham Nigussie Mekuria, Assefa Tola, Kirubel Minsamo Mishore, and Fisseha Bonja Geleto. "Prescription drugs use during pregnancy in Ethiopia: A systematic review and meta-analysis." SAGE Open Medicine 8 (January 2020): 205031212093547. http://dx.doi.org/10.1177/2050312120935471.

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Background: The selection of safe drugs for pregnant women in developing countries, such as Ethiopia, where there are limited options of drugs would be challenging. Hence, the aim of this review was to determine the extent of prescribed drugs use and their potential to cause fetal harm among pregnant women in Ethiopia based on the United States Food and Drug Administration risk category. Methods: Relevant studies were identified through systematic searches conducted in PubMed, HINARI, Google Scholar and Researchgate. Data on study characteristics and outcomes were extracted using the format developed in Microsoft Excel. The primary measure was pooled prevalence of prescription drugs use during pregnancy. The I2 index was used to assess heterogeneity among studies. The presence of publication bias across studies was evaluated using funnel plot. A random effects model was used to estimate the pooled prevalence. Results: A total of nine studies published between 2013 and 2019 were included. The pooled prevalence of prescription drugs during pregnancy, excluding minerals and vitamins, was 45.9 (95%CI: 29.3, 62.5)%. The pooled prevalence of prescription drug use, including minerals and vitamins, was 86.9 (95%CI: 81.2, 92.6)%. The pooled proportion of medications used based on the United States Food and Drug Administration risk category was 56.1 (95%CI: 43.0, 68.4)%, 29.0 (95%CI: 27.9, 30.1)%, 12.1 (95%CI: 7.9, 18.1)%, 4.1 (95%CI: 3.6, 4.6)%, and 2.5 (95%CI: 1.8, 3.6)% for the United States Food and Drug Administration fetal risk category “A,” “B,” “C,” “D,” and “X,” respectively. Conclusion: The use of prescription drugs during pregnancy, excluding supplements, in Ethiopia was high. Drugs with evidence of fetal harm were widely used. Hence, health care providers should select relatively safe drugs. Stakeholders should ensure safe prescribing practice for pregnant women through developing guidelines and updating professionals on the fetal risk status of commonly prescribed drugs.

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Boozalis, Emily, Yevgeniy R. Semenov, and Shawn G. Kwatra. "Food and drug administration approval process for dermatology drugs in the United States." Journal of Dermatological Treatment 29, no. 6 (January 26, 2018): 536–38. http://dx.doi.org/10.1080/09546634.2018.1425361.

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Johnson, John R., Grant Williams, and Richard Pazdur. "End Points and United States Food and Drug Administration Approval of Oncology Drugs." Journal of Clinical Oncology 21, no. 7 (April 1, 2003): 1404–11. http://dx.doi.org/10.1200/jco.2003.08.072.

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Purpose: To summarize the end points used by the United States Food and Drug Administration (FDA) to approve new cancer drug applications over the last 13 years. Materials and Methods: The FDA granted marketing approval to 71 oncology drug applications between January 1, 1990, and November 1, 2002. The end points used as the approval basis for each application are presented, and the rationale for each end point is discussed. Results: The FDA grants either regular marketing approval or accelerated marketing approval for oncology drug applications. Regular approval is based on end points that demonstrate that the drug provides a longer life, a better life, or a favorable effect on an established surrogate for a longer life or a better life. Accelerated approval (AA) is based on a surrogate end point that is less well established but that is reasonably likely to predict a longer or a better life. Tumor response was the approval basis in 26 of 57 regular approvals, supported by relief of tumor-specific symptoms in nine of these 26 regular approvals. Relief of tumor-specific symptoms provided critical support for approval in 13 of 57 regular approvals. Approval was based on tumor response in 12 of 14 AAs. Conclusion: End points other than survival were the approval basis for 68% (39 of 57) of oncology drug marketing applications granted regular approval and for all 14 applications granted accelerated approval from January 1, 1990, to November 1, 2002.

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Sarvas, Holly, Benjamin Carlisle, Samantha Dolter, Esther Vinarov, and Jonathan Kimmelman. "Impact of Precision Medicine on Efficiencies of Novel Drug Development in Cancer." JNCI: Journal of the National Cancer Institute 112, no. 8 (November 13, 2019): 859–62. http://dx.doi.org/10.1093/jnci/djz212.

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Abstract Precision medicine (PM) offers opportunities for reducing the costs, burdens, and time associated with drug development. We examined time, number of trials, indications tested, and patient burden needed to achieve first U.S. Food and Drug Administration license for all five novel anticancer PM drugs and all 10 novel non-PM drugs receiving U.S. Food and Drug Administration approval during 2010–2014. The 15 drug portfolios encompassed 242 trials: 87 for PM drugs and 155 for non-PM drugs. Embase and MEDLINE databases were searched for all prelicensure clinical trials, and data on time, patient numbers, indications tested, and total treatment-emergent grade 3–5 adverse events were measured from the first trial of each drug. We did not find patterns suggesting greater efficiencies in PM compared with non-PM. Gains in efficiency for PM drug development may be offset by challenges with recruitment.

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da la Torre, Beatriz G., and Fernando Albericio. "Practical Protocols for Solid-Phase Peptide Synthesis 4.0." Methods and Protocols 5, no. 6 (October 24, 2022): 85. http://dx.doi.org/10.3390/mps5060085.

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Chambers, James D., Katherine A. Clifford, Daniel E. Enright, and Peter J. Neumann. "Follow-On Indications for Orphan Drugs Related to the Inflation Reduction Act." JAMA Network Open 6, no. 8 (August 15, 2023): e2329006. http://dx.doi.org/10.1001/jamanetworkopen.2023.29006.

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Bateman-House, Alison, Arthur Caplan, and Lisa Kearns. "Ensuring Justice in Access to Investigational Neurological Drugs." Seminars in Neurology 38, no. 05 (October 2018): 583–88. http://dx.doi.org/10.1055/s-0038-1668076.

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AbstractPatients who suffer from life-threatening illnesses or are stricken with conditions that could result in serious morbidity who have exhausted all appropriate treatments may choose to try, through the Food and Drug Administration's expanded access program, an investigational drug or device in development. The program has succeeded for decades in allowing patients to access potentially helpful but still experimental agents. Nevertheless, the administration of investigational drugs outside of clinical trials raises several ethical issues. Of particular concern are the validity of informed consent and the absence of a framework to ensure that experimental drugs are allocated justly and transparently. Although there are some safeguards to help protect the soundness of consent, little work to date has been done to guarantee that investigational medical products are allocated justly and transparently. We introduce a novel pilot project that seeks to address this issue.

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Romanach, John, and Walter E. Block. "Medical Economics: End the FDA (Food and Drug Administration)." Winners 18, no. 1 (March 31, 2017): 43. http://dx.doi.org/10.21512/tw.v18i1.4052.

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The aim of this research is to know what FDA was done to get pure food and drug. Was it to put all the eggs in one basket and entrust the objective to a monopolistic agency which suffers no financial losses when it errors or would the authors be better off relying on a private, competitive certification industry, the firms of which can earn profits for accurate assessments and losses for erroneous ones? Ensuring the quality of pharmaceuticals was concerned, the best and most efficient means toward that end was reliance on free enterprise. The method used was the literature review by applying what the authors knew about the difference between competition and monopoly to an arena where all too seldom was it applied. It finds that the FDA cannot eliminate risk; only deny people from taking the calculated risk in the hope of curing disease. Legislation such as the Compassionate Freedom of Choice Act has been introduced with the intention of empowering patients to make informed decisions and allow them to take drugs not approved by the FDA.

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Pearson, Kay C., and Dianne L. Kennedy. "Adverse Drug Reactions and the Food and Drug Administration." Journal of Pharmacy Practice 2, no. 4 (August 1989): 209–13. http://dx.doi.org/10.1177/089719008900200403.

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The monitoring of adverse drug reactions (ADRs) after a drug is marketed is an important mission for the US Food and Drug Administration (FDA). Currently, the FDA receives and computerizes nearly 60,000 ADR reports each year. The FDA has an active postmarketing surveillance system in place to effectively triage, tabulate, analyze, and evaluate these reports. Of highest priority to FDA are the discovery of serious reactions that were not observed before a drug was marketed and the detection of increased occurrence of serious reactions that are known to occur with the drug. All reactions for new moieties marketed in the United States during their first 3 years are of interest. Pharmacists are in a unique position to be aware of adverse reactions because of their knowledge of drugs, their close working relationships with other health care providers, and their direct interactions with patients. By participating in FDA's ADR reporting system, pharmacists can actively contribute to drug safety and help improve patient care. This is a US government work. There are no restrictions on its use.

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Tu, S. Sean, Aaron S. Kesselheim, Kathrine Wetherbee, and William B. Feldman. "Changes in the Number of Continuation Patents on Drugs Approved by the FDA." JAMA 330, no. 5 (August 1, 2023): 469. http://dx.doi.org/10.1001/jama.2023.11525.

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Kitchlew, Rizwana, Miqdad Haider, and Saba Mir. "Awareness about appropriate practice of Sodium Polystyrene Sulfonate administration." Professional Medical Journal 27, no. 01 (January 10, 2020): 52–56. http://dx.doi.org/10.29309/tpmj/2019.27.01.3184.

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In patients of Chronic Kidney Disease (CKD) one of the most frequent and threatening complication is hyperkalemia. Sodium polystyrene sulfonate (SPS) commonly known as Kayexalate is one of the treatment options in management of hyperkalemia. Food and Drug Authority (FDA) has recently issued a warning that SPS is not to be administered at the same time with other oral drugs. Objectives: To assess the prevailing concepts about Sodium Polystyrene Sulfonate administration and its interactions with other drugs among doctors and patients. Study Design: A Descriptive study. Setting: Three Tertiary Care Health Centers of Lahore. Period: 1st January 2018 till 31st July 2018. Material & Methods: The study population includes adult patients who had suffered from hyperkalemia, and the doctors who have been prescribing the drug and gave consent to participate in the survey. The statistical analysis was performed on SPSS version 23. Results: The total number of study participants were 75, where 50 were doctors and 25 were patients receiving Kayexalate treatment. The age range for doctors was between 24 to 55 years with mean age of 31.4 ±7.2 years. Among doctors 37 (74%) prescribe SPS at some interval from other medications, whereas only 4 (8%) prescribe at the interval recommended by FDA (3 hours). Only 19 (38%) said they knew about the latest guidelines of FDA about SPS interaction with other drugs and 38 (76%) had knowledge that SPS hampers absorption of other drugs. Among population comprising of patients receiving kayexalate, the age range was between 27 to 68 years with mean age of 49.2 ±8.5 years. 11 (44%) patients were advised to take this drug at some interval from other drugs. Conclusion: Hyperkalemia is commonly seen in tertiary care setups, especially in CKD patients. Kayexalate being an affordable option for its treatment, there is a need for improvement in training of doctors about its use and its interactions with food and other medications.

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Greenlees, Kevin J. "Animal Drug Human Food Safety Toxicology and Antimicrobial Resistance—The Square Peg." International Journal of Toxicology 22, no. 2 (March 2003): 131–34. http://dx.doi.org/10.1080/10915810305091.

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This paper presents the traditional approach for the evaluation of human food safety used for animal drugs intended for food animals, and describes some of the difficulties posed by antimicrobial drug resistance. Like human drugs, animal drugs must be safe and effective for the patient. However, unlike human drugs, food derived from animals treated with the animal drug must also be shown to be safe for human consumption. The Food and Drug Administration has come to realize that antimicrobial drugs used in the treatment of the food animal have the potential to create a unique residue—increased numbers of microorganism that are resistant to antimicrobial drug treatment. The traditional toxicological paradigm for chemical residues does not apply to this unique microbiological residue. Information useful to a food safety evaluation may include the potential for the animal antimicrobial drug to diminish the susceptibility of microorganisms to human antimicrobial drugs, any human medical use of the drug, relationship to other human antimicrobial drugs, and the ability of the animal drug to alter the susceptibility of relevant microorganism to important human antimicrobial drugs. Yet to be developed are standardized approaches to quantify an acceptable level of resistant microorganism in food and to mitigate the hazard to assure that there is a reasonable certainty of no harm following the consumption of the edible food derived from the treated animal.

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Naci, Huseyin, Robin Forrest, Mike Zhai, Amanda R. Stofesky, and Aaron S. Kesselheim. "Characteristics of Prior Authorization Policies for New Drugs in Medicare Part D." JAMA Health Forum 4, no. 2 (February 24, 2023): e225610. http://dx.doi.org/10.1001/jamahealthforum.2022.5610.

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This cross-sectional study examines the characteristics of prior authorization policies for new drugs in Medicare Part D to understand whether they are consistent with US Food and Drug Administration indications.

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Dhodapkar, Meera M., Joseph S. Ross, and Reshma Ramachandran. "US Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019." JAMA Network Open 6, no. 6 (June 26, 2023): e2318889. http://dx.doi.org/10.1001/jamanetworkopen.2023.18889.

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Mason, Marlys J. "Drugs or Dietary Supplements: FDA's Enforcement of DSHEA." Journal of Public Policy & Marketing 17, no. 2 (September 1998): 296–302. http://dx.doi.org/10.1177/074391569801700212.

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The Dietary Supplement Health and Education Act broadened the definition of a dietary supplement and loosened the restrictions for health claims on supplement labeling. The Act has left an unclear boundary between supplements and drugs. In this article, the author examines the legal debate surrounding the definition and regulation of drugs and supplements. The author also discusses recent Food and Drug Administration enforcement activities and court challenges.

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Salman, Mohammad, Syed Allahsan, Manzoor Mahmood, Md Khairul Anam, Shahed Mohammad Anwar, Roksana Afrose, Md Abu Afrose, Md Ashraf Uddin Sultan, and Fazlur Rahman. "New Drugs for Acute Heart Failure." University Heart Journal 7, no. 1 (March 29, 2012): 35–38. http://dx.doi.org/10.3329/uhj.v7i1.10208.

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Acute heart failure is a major health problem responsible for several million hospitalizations worldwide each year. Standard therapy has not changed for long time and includes diuretics and variable use of vasodilators or inotropes. Recently Nesiritide and Levosimendan are two drugs for the treatment of acute heart failure which have been approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMEA), respectively. There was little concern that Nesiritide can worsen the renal failure but recent trials had abolished this concern. DOI: http://dx.doi.org/10.3329/uhj.v7i1.10208 UHJ 2011; 7(1): 35-38

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Fricker, Lloyd D. "Proteasome Inhibitor Drugs." Annual Review of Pharmacology and Toxicology 60, no. 1 (January 6, 2020): 457–76. http://dx.doi.org/10.1146/annurev-pharmtox-010919-023603.

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Proteasomes are large, multicatalytic protein complexes that cleave cellular proteins into peptides. There are many distinct forms of proteasomes that differ in catalytically active subunits, regulatory subunits, and associated proteins. Proteasome inhibitors are an important class of drugs for the treatment of multiple myeloma and mantle cell lymphoma, and they are being investigated for other diseases. Bortezomib (Velcade) was the first proteasome inhibitor to be approved by the US Food and Drug Administration. Carfilzomib (Kyprolis) and ixazomib (Ninlaro) have recently been approved, and more drugs are in development. While the primary mechanism of action is inhibition of the proteasome, the downstream events that lead to selective cell death are not entirely clear. Proteasome inhibitors have been found to affect protein turnover but at concentrations that are much higher than those achieved clinically, raising the possibility that some of the effects of proteasome inhibitors are mediated by other mechanisms.

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Hermida, Laura G., Manuel Sabés-Xamaní, and Ramon Barnadas-Rodríguez. "Characteristics and behaviour of liposomes when incubated with natural bile salt extract: implications for their use as oral drug delivery systems." Soft Matter 10, no. 35 (2014): 6677–85. http://dx.doi.org/10.1039/c4sm00981a.

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Cupic, Vitomir, Sasa Ivanovic, Suncica Borozan, Indira Mujezinovic, Dejana Cupic-Miladinovic, and Jelena Aleksic. "Antimicrobial agents in laying hens." Zbornik Matice srpske za prirodne nauke, no. 142 (2022): 61–71. http://dx.doi.org/10.2298/zmspn2242061c.

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The European Union permitted 6 antimicrobial agents that can be used in laying hens. These are colistin, tyrosine, neomycin, oxytetracycline, chlortetracycline, and erythromycin. Antimicrobial drugs are used today primarily for the prevention and treatment of diseases in poultry and often (not in the EU) to stimulate growth. Because these drugs are often used irrationally, there are good chances that their residues will be found not only in poultry meat but also in the eggs within a certain period after the termination of treatment. In addition to the administration of authorised VMPs, the residues in eggs can be the result of erroneously applied medicated food, the contamination of the food with some antimicrobial drug in the mixing unit, as well as ?extra-label? use of drugs in poultry. The antimicrobial agents are distributed in the body and deposited in the eggs, mainly in the yolk where they persist longer than in the albumen. Drugs that are poorly absorbed from the gastrointestinal tract (aminoglycosides, aminocyclitols, polymyxins) cannot be detected in the eggs, while the residues of some antimicrobial drugs can be detected for up to two months (chloramphenicol) after the last treatment. The rational use of drugs in veterinary medicine has manifold significance. When using drugs only when they are really necessary (indicated), in the right dose and route of administration, the potential damage can be reduced and efficiency increased, while the risk of microorganism resistance development would be significantly decreased. All of this becomes more important when these drugs are used in food animals.

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Pivarnik, Greg. "Cells as Drugs?: Regulating the Future of Medicine." American Journal of Law & Medicine 40, no. 2-3 (June 2014): 298–321. http://dx.doi.org/10.1177/009885881404000208.

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Regenerative Sciences, LLC, a Colorado company run by physicians, created the Regenexx-C (Cultured) (“Regenexx-C”) procedure to treat bone pain. The procedure involves harvesting a patient’s own mesenchymal stem cells (MSCs), expanding the cells ex vivo, and then injecting the resulting cellular product into the site of injury, usually an injured joint. The MSCs then repair the damaged tissue. On July 23, 2012, the United States Food and Drug Administration (FDA) won a permanent injunction against Regenerative Sciences in district court, preventing the company from offering the procedure because the MSCs were adulterated and misbranded “drugs” under the Federal Food, Drug, and Cosmetic Act (FDCA). The Court of Appeals for the D.C. Circuit recently upheld the ruling.

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Smetana, Gerald W. "Update on Novel Drugs for Primary Care Practice: Drugs Approved by the U.S. Food and Drug Administration in 2015." Annals of Internal Medicine 164, no. 9 (May 3, 2016): W48. http://dx.doi.org/10.7326/m15-3104.

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Baldwin, Paul. "The Regulation of Dietary Supplements in the United States." Senior Care Pharmacist 37, no. 8 (August 1, 2022): 374. http://dx.doi.org/10.4140/tcp.n.2022.374.

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Is it legal to make health claims for a product sold in the United States without being required to prove those claims? Yes, but only if those claims relate to dietary supplements, not drugs. The world of dietary supplement regulation is quite unlike any other. First, dietary supplements are not drugs, but "food" in the regulatory scheme. The US Food and Drug Administration has no authority to approve or deny approval to manufacturers for the marketing of dietary supplements. There is, however, a general prohibition against marketing drugs that are "adulterated or misbranded." The author discusses information for pharmacists relative to this topic.

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Milutinov, Jovana, Veljko Krstonošić, Dejan Ćirin, and Nebojša Pavlović. "Emulgels: Promising Carrier Systems for Food Ingredients and Drugs." Polymers 15, no. 10 (May 13, 2023): 2302. http://dx.doi.org/10.3390/polym15102302.

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Novel delivery systems for cosmetics, drugs, and food ingredients are of great scientific and industrial interest due to their ability to incorporate and protect active substances, thus improving their selectivity, bioavailability, and efficacy. Emulgels are emerging carrier systems that represent a mixture of emulsion and gel, which are particularly significant for the delivery of hydrophobic substances. However, the proper selection of main constituents determines the stability and efficacy of emulgels. Emulgels are dual-controlled release systems, where the oil phase is utilized as a carrier for hydrophobic substances and it determines the occlusive and sensory properties of the product. The emulsifiers are used to promote emulsification during production and to ensure emulsion stability. The choice of emulsifying agents is based on their capacity to emulsify, their toxicity, and their route of administration. Generally, gelling agents are used to increase the consistency of formulation and improve sensory properties by making these systems thixotropic. The gelling agents also impact the release of active substances from the formulation and stability of the system. Therefore, the aim of this review is to gain new insights into emulgel formulations, including the components selection, methods of preparation, and characterization, which are based on recent advances in research studies.

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Journal articles on the topic 'FOOD AND DRUGS ADMINISTRATION'

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