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
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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#CBEROTP published a new draft guidance with recommendations for determining the appropriate cell safety testing to support IND and BLA submissions for allogeneic cell-based medical products. Submit comments on this draft guidance through July 29, 2024. https://bit.ly/3xVD3HP
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If you work on over-the-counter (OTC) monograph drug products or non-prescription drugs, don’t miss this webinar! FDA experts will offer an overview of the Over-the-Counter Drug User Fee Program (OMUFA) and provide valuable information about fees, registration, timelines, and more. This course has been pre-approved by RAPS, SOCRA, SQA and ACRP, and also offers one contact hour of CME/CPE/CNE. 🔔 Register today! ➡ https://lnkd.in/dafKebhU
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 Use
fda.gov
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Did you know that Artificial Intelligence (AI) is gaining traction in clinical research and changing the clinical trial landscape? Listen in to learn more in this Q&A with FDA podcast with Dr. Khair ElZarrad, Director of CDER’s Office of Medical Policy, and recipient of the 2023 Arthur S. Fleming Award, which honors outstanding federal employees: https://lnkd.in/g7wJvnUi
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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
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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