Join FDA's Oncology Center of Excellence for the 9th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop, June 25, 2024, 11 am to 2:30 pm ET. Each year, the COA-CCT workshop provides a forum for multidisciplinary discussions to advance the understanding of regulatory, health care policy, and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials. Agenda and session panelist biographies now posted. View event details and register now! https://lnkd.in/e5Zjjr8D #OCEOutcomes24
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.
- Website
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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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Primary
10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
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Happy #WorldFoodSafetyDay2024! 🎉 This year's theme from FAO and World Health Organization is “Food Safety: Prepare for the Unexpected.” Join the FDA on World Food Safety Day as we spread the word about ways to reduce the risks of foodborne illness, aka food poisoning. https://lnkd.in/ebP5CwD FDA is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled. Remember, food safety is everyone’s business. #foodsafety #worldfoodsafetyday
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📣Join FDA and Clinical Trials Transformation Initiative (CTTI) August 6, 2024 (10:00 AM - 5:30 PM EDT) for a free hybrid public workshop on artificial intelligence (AI) in drug and biological product development. AI holds great potential to transform how drugs are developed, manufactured, and utilized. As with any innovation, AI use in drug development creates new and unique challenges that require both careful management and a risk-based regulatory framework that is built on sound regulatory science approaches. This public workshop will explore guiding principles that are being applied by innovators and regulators to promote the responsible use of AI in the development of safe and effective drugs. Register today ➡️ https://lnkd.in/eP99VH_2
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Primary care providers: Want to learn more about how you can directly address the opioid epidemic? Find resources about diagnosing opioid use disorder and prescribing life-saving medication to treat it at: https://lnkd.in/efqZRyNj. #PrescribeWithConfidence #MOUDSavesLives #oud #MedEd #recovery
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FDA has published a draft guidance for industry describing the processes and practices applicable to our Bioresearch Monitoring (BIMO) program’s inspections of sites and facilities, as conducted in accordance with section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act. Specifically, this draft guidance addresses the following (to the extent not publicly available in FDA guides and manuals): the types of records and information required to be provided, best practices for communication between FDA and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct. FDA is issuing this draft guidance to comply with section 3612(b)(2) of the Food and Drug Omnibus Reform Act of 2022 (FDORA), enacted as part of the Consolidated Appropriations Act, 2023. The deadline for submitting comments to the docket is August 5, 2024. https://lnkd.in/eVkEcEsN
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DYK - Hurricane Season started on June 1st? If you are a human and/or animal food producer, the FDA encourages you to be prepared! We have updated the federal and state resources for human and animal food producers who may need help after a severe or inclement weather event. #hurricaneprep #farmers Learn more:
Resources for Human and Animal Food Producers Affected by Flooding
fda.gov
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Today, FDA is providing an update on the status of the agency’s review of the premarket tobacco product applications (PMTAs) submitted by JUUL Labs, Inc. Read more: https://lnkd.in/drTkbF7h
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Today the FDA is sharing preliminary findings from a multi-year environmental study within a specific Southwest growing region. The study sought to better understand the ecology of human pathogens in the environment in the Southwest agricultural region. https://lnkd.in/ejfRuuMa This longitudinal study was done in partnership with the Arizona Department of Agriculture, University of Arizona Cooperative Extension, Wellton-Mohawk Irrigation & Drainage District, and the leafy greens industry. The research team intends to present this study during the International Association for Food Protection annual meeting in July 2024.
Findings from Multi-year Environmental Study
fda.gov
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In this episode of "On the Road with Jim" our Deputy Commissioner for Human Foods, James Jones, traveled to Georgia meeting with federal partners and academic stakeholders at UGA College of Agricultural and Environmental Sciences Center for Food Safety, Centers for Disease Control and Prevention, Commissioner Tyler Harper at Georgia Department of Agriculture, and the FDA Atlanta District Office and Labs. https://lnkd.in/gWG96wjC
U.S. Food and Drug Administration
fda.gov
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We can achieve anything when we collaborate, says Emer Cooke, executive director of the European Medicines Agency (EMA). Read about her passion for international cooperation and harmonization, as well as a 30-year career in medicines regulation in a variety of roles at European and international organizations. The interview, which took place after FDA Commissioner Dr. Robert Califf ‘s trip to the EMA in February and April’s FDA-EU Bilateral in Washington, is the latest feature in OGPS’ publication “From a Global Perspective.” https://lnkd.in/eR8eU__f