Join us for a #virtual listening meeting on 9/20 to share perspectives on safety considerations for approved #GeneTherapy treatments for #RareDiseases and participation in long-term studies after receiving gene therapy. Register to speak by 8/30: https://bit.ly/3XUEQrP
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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Today, we approved the first nasal spray for the emergency treatment of allergic reactions, including life-threatening anaphylaxis, in adult and pediatric patients who weigh at least 66 pounds. https://lnkd.in/e9RYz7X2
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FDA approves an auto-injector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age & older: https://lnkd.in/ezRjWN6D
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Join us on November 19 from 8:30 AM to 4:30 PM for the advisory committee meeting to discuss reevaluation of the Clozapine Risk Evaluation and Mitigation Strategy (REMS): https://lnkd.in/eBZxK_pv
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FDA CBER releases Demographic Data Summaries for CBER Novel Biological Approvals by Year https://lnkd.in/eQufmQ-f
U.S. Food and Drug Administration
fda.gov
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@FDACBER is hosting a #virtual town hall on 9/5 to answer questions related to CMC readiness for late-stage INDs for #CellTherapy and tissue-engineered products. Register today and submit questions to #FDA experts in advance of this event. https://bit.ly/3LqCoSs
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Pediatric cancer advocates—we want to hear from you! Registration is open for the Oct. 15 FDA Oncology Center of Excellence Pediatric Advocacy Forum. Options for in-person or virtual attendance. Registration is free. Event details: https://lnkd.in/eGAUxugc #Pediatric #Cancer #PatientAdvocacy
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Today, we released the 2024 Language Access Plan. This plan outlines how the FDA will expand upon its language access efforts and provide meaningful access to people with disabilities and people with limited English proficiency. https://lnkd.in/eBP3Wpmb
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#ICYMI: 🎥 Watch and learn about essential regulatory information on how to engage with FDA and gain information about ANDA development and ANDA assessment. 🔎 View the Generic Drugs Forum (GDF) 2024 recordings here ➡ https://lnkd.in/eyCjeDjx
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FDA is extending the comment period starting August 8 for the recently issued Proposed Administrative Order: Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use: https://lnkd.in/eY4SxJih Submit any comments regarding the proposed order addressed in this notice to the public docket available at https://lnkd.in/gR_Jfaw until September 29, 2024.