We have issued an update to our Letter to Health Care Providers with new information regarding our ongoing evaluation on the potential for exposure to airborne chemicals that may be released from neonatal incubators. Find out more: https://lnkd.in/eUfneNgX
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
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10903 New Hampshire Ave
Silver Spring, MD 20993, US
Employees at FDA
Updates
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This #NationalSTEMDay, we celebrate the critical role that science, technology, engineering, and mathematics play in ensuring drug safety. Our commitment to rigorous scientific processes 🧪 and cutting-edge technology gives health care providers confidence in the treatments they prescribe. Explore how #STEM fields contribute to the FDA’s drug safety efforts by watching our video series, available in English and Spanish ➡️ https://bit.ly/4fZdXt4 #Innovation
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🧪🔬 #NationalSTEMDay Quiz:
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Join FDA’s Center for Drug Evaluation and Research and Duke-Margolis Institute for Health Policy on December 12, 2024 for a public hybrid workshop, Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products- Looking Forward, to discuss potential next steps to promote the continued evolution and consistent application of real-world data in drug development. We encourage in-person participation. Please register by Friday, December 6, 2024. Registration is free and based on available space due to limited seating. Early registrants will have priority. Register ➡️ https://lnkd.in/eRf_pjeN
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Ahead of this month's 13th Meeting of the WHO Member State Mechanism on Substandard and Falsified Medical Products, read what Mark Abdoo, FDA Associate Commissioner for Global Policy and Strategy, has to say about how to make the Mechanism more effective. It's the latest in our blog series From a Global Perspective, occasional thought pieces on international topics from experts across the FDA. https://lnkd.in/ewqnkJVN
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Don't miss this opportunity to be part of a crucial conversation on sustainability in inhaler technology. Join FDA and the Center for Research on Complex Generics for the “Navigating the Transition to Low Global Warming Potential Propellants” hybrid workshop on Dec. 4-5, 2024. Learn more: https://lnkd.in/eCrmyt8G
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We have updated our Breakthrough Device designations data, including the number of breakthrough devices that have received marketing authorizations. From the launch of the Breakthrough Devices Program through September 30, 2024, the FDA has: • granted 1,041 devices Breakthrough Device designation. o 1,029 from the Center for Devices and Radiological Health (CDRH) o 12 from the Center and for Biologics Evaluation and (CBER) • authorized 128 Breakthrough Devices for marketing. The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to certain medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Find out more: https://lnkd.in/gu65mxSf
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Today, the FDA is seeking public input on its current approach to managing FDA certification or export lists for the export of human food products that are regulated by the agency. This RFI is intended to gather input from all impacted stakeholders to help the FDA Human Food Program ensure it is considering the full range of perspectives when planning and resourcing changes and/or improvements to the export list component of the Export Certification Program. https://lnkd.in/eER4fGVQ
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FDA is proposing to remove oral phenylephrine as an active ingredient that can be used in over-the-counter (OTC) monograph drug products for the temporary relief of nasal congestion after review of the available data determined that it is not effective for this use. The FDA is seeking public comments on this proposed order. If, after considering the comments, FDA concludes oral phenylephrine is not effective as a nasal decongestant, we will issue a final order removing oral phenylephrine from the OTC monograph, and drug products thereafter could no longer contain oral phenylephrine as a nasal decongestant. The FDA would provide manufacturers with appropriate time to either reformulate drugs containing oral phenylephrine or remove such drugs from the market. Learn more: https://lnkd.in/e5pXdF4h
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Today, on India's National Cancer Awareness Day, the U.S. Food and Drug Administration was honored to participate in the ICMR-PGIMER Workshop in Chandigarh on Phase 1 Clinical Trials, focusing on regulatory aspects crucial to advancing cancer research. The FDA team — Dr. Geetika Srivastava from the Oncology Center of Excellence; Greg Smith, Director of the FDA India Office; Investigator Courtney Long; and Dr. Phillip Nguyen, Senior Policy Advisor — delivered lectures and engaged in case discussions on Phase 1 trials, a pivotal component in the R&D of new drugs. We were also joined by HHS Senior Advisor Dr. Syed Asrafuzzaman, who delivered welcome remarks, underscoring the Department of Health and Human Service's commitment to support US-India health collaborations. By fostering international collaboration and sharing expertise, we aim to support India’s regulatory community in strengthening knowledge on clinical trials advancing cancer treatment options. #ClinicalTrials #CancerResearch #FDAIndia #GlobalHealth #CancerAwareness
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