Thank you to everyone participating in the #CDERSBIA REdI Conference this week. The conference has been recorded and is available to view. Understanding best practices of how to get #medicaldevices to market is key in ensuring that they are safe and effective. We truly enjoyed speaking to and hearing from you during the CDRH Devices track. https://lnkd.in/eiP_EDxt #MedicalDevice #FDA
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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📢 Join us for our free CE webinar on June 18 from 1-2 PM ET, to learn how to use the Orange Book to find therapeutic equivalence, marketing status, patents, and exclusivities information, including a discussion on commonly asked questions. Register here ➡️ https://lnkd.in/eeFnQuU9
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On May 29, 2024, FDA notified selected participants of their acceptance into the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program: https://lnkd.in/eFNrXnCV Announced in September 2023, the pilot is an FDA initiative to help further accelerate the development of novel drug and biological products for rare diseases.
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Spring has been a busy time for FDA's international efforts, whether it's with the World Health Organization, with other strategic partners, or in our foreign offices. Read all about it in the May issue of the Global Update, from the FDA's Office of Global Policy and Strategy. https://lnkd.in/ePGYgTaJ
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Recently, the FDA’s Center for Devices and Radiological Health (CDRH) began participating in three new collaborative communities in the medical device ecosystem. These new collaborative communities focus on topics related to implantable brain-computer interfaces, pulse oximeters, and Smart and Autonomous Medical Systems. Learn more about the Implantable Brain-Computer Interface Collaborative Community, the OpenOximetry Collaborative Community, and the Smart and Autonomous Medical Systems Collaborative Community: https://lnkd.in/gY3Mwfav
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Today, FDA reached a significant milestone with approval of its reorganization efforts involving the creation of a unified Human Foods Program, adoption of a new model for field operations and other modernization improvements, effective on Oct. 1. https://lnkd.in/eN7uQVeW
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Today, FDA announced it is seeking civil money penalties (CMPs) from nine brick and mortar retailers and one online retailer for the sale of Elf Bar. FDA previously issued warning letters to these retailers for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations. Accordingly, the agency is now seeking a CMP of $20,678 from each retailer. https://lnkd.in/d8c9aFcK
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Attending #ASCO24? FDA Oncology Center of Excellence experts will be speaking at the American Society of Clinical Oncology (ASCO) Annual Meeting May 31-June 4 in Chicago and online. Add these talks to your calendar! https://lnkd.in/e86wfsMn