FDA’s cover photo
FDA

FDA

Government Administration

Silver Spring, MD 883,946 followers

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
http://www.fda.gov/
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

Employees at FDA

Updates

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    UPDATE: The FDA and Centers for Disease Control and Prevention have updated their advisories with new cases. https://lnkd.in/ekWtuV_A The Agency has received reports that recalled ByHeart infant formula is still appearing on some store shelves. REMINDER: All ByHeart Infant Formula products have been recalled. Do not buy or use this formula, even if you see it for sale.

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    RECALL UPDATE: All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks. https://lnkd.in/ekWtuV_A

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    Every cancer journey is personal—especially for older adults navigating complex care decisions.    Join FDA Oncology and a panel of experts for Conversations on Cancer: Empowered Choices, a discussion focused on decision-making, patient values, and inclusion of older adults in clinical research.    📅 December 11, 2025 | 💻 Virtual event  https://lnkd.in/ep94yfsT

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    The FDA is hosting a public workshop to address potential barriers limiting access to life-saving epinephrine treatment for anaphylaxis. Key highlights: • Anaphylaxis affects up to 5% of Americans, causing ~200 deaths annually • Workshop examines regulatory and policy solutions • Virtual format allows broad stakeholder participation • Free registration open through Dec. 16, 2025 • Seeking input from healthcare professionals, patient advocates, schools, and community organizations   Anaphylaxis is a severe allergic reaction requiring immediate epinephrine treatment. Potential barriers to accessing and using this life-saving medication include individual access challenges, institutional policy gaps, and geographic disparities. This workshop represents FDA's commitment to improving public health outcomes through collaborative solutions.   Register: https://duke.is/EpiAccess Workshop Date: Dec. 16, 2025, 9 a.m. – 4:30 p.m. ET

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    Today, FDA approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin. [https://lnkd.in/g2uHypkb]     This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners.    The pembrolizumab prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity. The enfortumab vedotin-ejfv prescribing information includes warnings and precautions for skin reactions, hyperglycemia, pneumonitis/interstitial lung disease (ILD), peripheral neuropathy, ocular disorders, infusion site extravasation, and embryo-fetal toxicity.   Learn more in the FDA-approved prescribing information at: https://lnkd.in/emUfeBq

    • FDA approves a treatment for muscle invasive bladder cancer. 
FDA logo in the lower right corner and blue and red stars at the bottom in the center.
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    FDA has issued a Federal Register notice announcing a virtual Tobacco Products Scientific Advisory Committee (TPSAC) meeting on Jan. 22, 2026, to discuss modified risk tobacco product (MRTP) applications from Swedish Match USA, Inc. for ZYN nicotine pouch products. https://lnkd.in/ePsSEz5M In Jan. 2025, FDA authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. The manufacturer is now seeking to market the products with a modified risk claim, which requires an additional authorization from the FDA.

    • Calendar page showing January 22-23 with "ZYN MRTP TPSAC Meeting" circled in red on January 23. A white container with white pouches is positioned next to the calendar, with several pouches scattered nearby. Red and blue stars appear at the bottom of the image. FDA logo is displayed in the bottom right corner.
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    Today, the FDA issued an Emergency Use Authorization for Credelio CAT for the treatment of New World screwworm infestations in cats and kittens. https://lnkd.in/e3mgPRt8 Based on current scientific evidence, the agency reasonably concluded the drug is effective in treating the disease, and the known and potential benefits outweigh the known and potential risks.

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    Exciting Educational Opportunity for Pediatric Hematology/Oncology Professionals    The FDA announces a new educational collaboration with the American Society of Pediatric Hematology Oncology (ASPHO) designed specifically for early career pediatric hematology/oncology clinicians and researchers.  This comprehensive program addresses a critical gap in training by providing participants with foundational knowledge of pediatric hematology/oncology drug development and the regulatory review process. Understanding these complex processes is essential for advancing treatments for children with blood disorders and cancer.    Program Structure: • In-person kickoff session at the 2026 ASPHO Annual Meeting in Minneapolis, MN, to be held from April 29-May 2 • Seven monthly virtual sessions (approximately 3 hours each) • Expert-led curriculum covering regulatory pathways and drug development    Application Timeline: The application deadline is December 29, 2025.    This FDA-ASPHO collaboration represents our continued commitment to supporting the next generation of pediatric specialists and advancing therapeutic options for children. We encourage eligible clinicians and researchers to apply for this unique learning opportunity. https://lnkd.in/efGgZniw   #PediatricOncology #FDA #MedicalEducation #DrugDevelopment #ASPHO #PediatricHematology 

    • FDA ASPHO Education Program announcement graphic featuring the FDA and ASPHO (American Society of Pediatric Hematology/Oncology) logos. Text reads "Applications OPEN NOW!" with a gold awareness ribbon symbol. The background shows a dandelion with seeds blowing in the wind against a green bokeh background, with decorative red and blue stars at the bottom.

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