FDA is issuing exemptions from certain requirements of section 582 of the Food, Drug and Cosmetic Act to small dispensers (pharmacies), and where applicable their trading partners, until November 27, 2026: https://lnkd.in/eyuGwzgr This provides small dispensers additional time to stabilize their operations to fully implement the enhanced drug distribution security requirements of the Drug Supply Chain Security Act (DSCSA).
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 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
Get directions
10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
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📣Join FDA & the Foundation for the National Institutes of Health on June 24-25 for a hybrid public workshop to discuss the effective integration of Digital Measures into clinical trials and medical product development. Learn more and register today ss ss https://lnkd.in/eVcmAmN6
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Join the Conversation! Starting now, Conversations on Cancer: 4th Annual National Black Family Cancer Awareness Week, Engaging the Generations, #BlackFamCan, with the FDA Oncology Center of Excellence and a panel of invited guests on efforts to increase cancer awareness, prevention, treatment access, and awareness of clinical trials, among vulnerable Black communities in the U.S. #CancerMoonshot https://lnkd.in/eK4rtqx2
4th Annual National Black Family Cancer Awareness, Engaging the Generations, #BlackFamCan
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In this CDER Conversation, Dr. Robert Ball, Deputy Director, Office of Surveillance & Epidemiology, explains the Emerging Drug Safety Technology Meeting (EDSTM) program and the application of artificial intelligence (AI) in pharmacovigilance: https://lnkd.in/eRg7K7GB
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Today, the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly issued the “Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles.” For a machine learning-enabled medical device, effective transparency ensures that information that could impact risks and patient outcomes is communicated to all the people who could be interacting with the device, including health care providers, payors, and others, to help make informed decisions. The Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles build upon the "Good Machine Learning Practice (GMLP) for Medical Device Development: Guiding Principles" and the "Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles" both published jointly by the FDA, Health Canada and MHRA. Transparency across health care is an international priority, and the FDA will continue to collaborate with international partners in this area. https://lnkd.in/dK-X6-Zw https://lnkd.in/ejqWRmV3
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Today, FDA announced the issuance of warning letters to six online retailers for selling unauthorized e-liquid products from the Bad Drip brand that imitate prescription drug bottles. The retailers were also warned for selling unauthorized flavored, disposable e-cigarettes, including those under the brand names Funky Republic and HQD. https://lnkd.in/dsz_KY3W
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CDER has added three examples of Bayesian statistical analysis plans to the CDER Center for Clinical Trial Innovation (C3TI)’s Bayesian Supplemental Analysis Demonstration (BSA) Project, which seeks to advance the understanding of Bayesian statistical methods and establish processes for integrating these approaches into clinical trial design in the future: https://lnkd.in/erjaDSpy
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Exciting news! FDA CDER will be participating in a panel discussion on osteoporosis and biosimilars at the Bone Health and Osteoporosis Foundation's Interdisciplinary Symposium taking place from June 13-15, 2024. Join us to learn about the latest advancements in treatment options and the role of biosimilars in managing osteoporosis. Don’t miss this opportunity to hear from leading experts in the field! For more details, visit https://bit.ly/3Vu6hHn. #Biosimilars #Osteoporosis #FDA #HealthcareInnovation #ISO2024
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Primary care providers can make a real difference in the lives of patients with OUD. Dr. Matthew Hahn, a family physician in rural Maryland, shares a story of success. Learn more at: https://lnkd.in/eaE8DRvf #PrescribeWithConfidence #MOUDSavesLives
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CDER’s collaboration with global regulators on pharmaceutical quality and inspections has resulted in the approval of new manufacturing and quality control sites for five different medicines. The efforts also resulted in three hybrid inspections where one regulator was on-site and others participated remotely. A full report on the findings of these efforts will be published by the International Coalition of Medicines Regulatory Authorities (ICMRA) in the coming months. For more information on how our collaboration with global regulators benefits patients and consumers in the U.S. and worldwide read our From Our Perspective: https://lnkd.in/e4wtjkY7
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