Clinical trial diversity initiatives and multiregional strategies can be complementary, according to an article by FDA experts just posted in the New England Journal of Medicine. "When Diversity Goals Meet Multiregional Trials" by Drs. Gautam Mehta, Richard Pazdur, Namandje Bumpus and Robert Califf. https://lnkd.in/e45_EYtq #oncology #clinicaltrials #drugdevelopment
About us
The Food and Drug Administration is an agency within the Department of Health and Human Services. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
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http://www.fda.gov/
External link for FDA
- Industry
- Government Administration
- Company size
- 10,001+ employees
- Headquarters
- Silver Spring, MD
- Type
- Government Agency
- Specialties
- Food, Drugs, Medical Devices, Vaccines Blood and Biologics, Animal and Veterinary, Cosmetics, Radiation-Emitting Products, Tobacco Products, Regulatory Research, and Toxicological Regulatory Research
Locations
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10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
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CDER has finalized the rule, Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU). The rule is intended to increase options for drug companies to develop and market safe and effective nonprescription drugs. This rule has the potential to increase the types of drugs available without a prescription from a health care professional. Learn more: https://lnkd.in/eCzBzpwS
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FDA issued the Federal Register notice (FRN), Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence, to encourage the submission of supplemental new drug applications to modify the labeling statements for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs). Learn more about the recommendations and read the FRN below: https://lnkd.in/e2bSeR_B
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Today, we announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products. This proposed rule, if finalized, will help protect consumers who use talc-containing cosmetic products from harmful exposure to asbestos. https://lnkd.in/e9JWT2We
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Last year drug companies created over 140,000 drug-related promotional pieces. Learn how to recognize & report potentially false or misleading prescription drug promotion with FDA’s Bad Ad Program and its free course and real-life case studies: http://www.fda.gov/BadAd #FDABadAd
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FDA approved a treatment for metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. Learn more: https://lnkd.in/gpTkwju6
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FDA updates its Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products, which finalizes the frequently asked questions and answers (FAQ) in Appendix B (Q1-19). In addition, three new FAQ in Appendix B of this guidance (Q20-22) are marked “for comment purposes only” to provide an opportunity for comment before they are finalized. The three new FAQ address the following topics: responsibilities of a U.S. agent, situations when one FDA Establishment Identifier (FEI) number may be associated with multiple buildings that manufacture or process cosmetic products, and product listings for free samples or gifts. FDA first issued a final guidance for industry on cosmetic product facility registrations and product listings in December 2023, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). At that time, FDA asked for comments on the FAQ in Appendix B (Q1-19). The guidance assists stakeholders with requirements for cosmetic product facility registration and product listing submissions to FDA by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, when to submit, and certain exemptions to the registration and listing. You can review the guidance document and the commenting period for the three new FAQ in Appendix B (Q20-22) at: https://lnkd.in/dskNCXFn
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As part of our continuing efforts to assess the safety of tampons, the FDA commissioned an independent, systematic literature review (SLR) and initiated a laboratory study on metals in tampon materials. The SLR review is now complete, and the FDA is sharing the report. The literature review’s findings continue to support the FDA’s testing requirements for tampons and the agency continues to recommend FDA-cleared tampons as a safe option for use as a menstrual product. https://lnkd.in/eji5QdD5
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FDA approves of the first generic of Victoza (liraglutide) injection: https://lnkd.in/eN5mk-eP You can search for the prescribing information, when available, on DailyMed: https://lnkd.in/g2V--8Ai
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