FDA

FDA

Government Administration

Silver Spring, MD 806,303 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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    FDA approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain. This is the first drug to be approved in this new class of pain management medicines. Journavx is contraindicated for concomitant use with strong CYP3A inhibitors. Additionally, patients should avoid food or drink containing grapefruit when taking Journavx. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Reduce dosage in patients with moderate hepatic impairment as use may increase the risk of adverse reactions. The most common adverse reactions in study participants who received Journavx were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. Learn more in the FDA-approved prescribing information below and at: https://lnkd.in/dUUs3fxB.

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    FDA has recently discovered through testing that several cosmetic products marketed as gel nail polish remover contain methylene chloride. Methylene chloride is a volatile, colorless liquid with a sweet odor that is used in various industrial processes, including paint stripping, paint remover manufacturing, and metal cleaning and degreasing. U.S. federal law prohibits methylene chloride as an ingredient in cosmetics because the chemical has been shown to cause cancer in animals and it can be harmful to human health. For more information on methylene chloride and to review the cosmetic products tested by the FDA and found to contain methylene chloride, please visit https://lnkd.in/e2BCeuKS. If you have questions, call your health care professional or the Poison Control Center at 1-800-222-1222; it is open 24 hours a day.

    • Closeup of hands using nail polish remover. Text reads cosmetics safety alert. FDA logo in corner.
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    FDA adds a Boxed Warning about a rare but serious allergic reaction called anaphylaxis with the multiple sclerosis medicine glatiramer acetate (Copaxone, Glatopa). Anaphylaxis can occur at any time while on treatment, after the first dose or after doses administered months or years after starting the medicine. For most patients who experienced anaphylaxis with glatiramer acetate use, the symptoms appeared within one hour of injection. In some cases, anaphylaxis resulted in hospitalization and death. The initial symptoms of anaphylaxis can overlap with those of a common reaction called immediate post-injection reaction that is temporary and can start soon after a shot is given. While immediate post-injection reaction is common, anaphylaxis is rare and its symptoms are typically more severe, worsen over time, and require treatment. Patients experiencing a reaction after the medicine is administered should seek immediate medical attention if the symptoms are more than mild, get worse over time, or do not go away within a brief time. Read the full Drug Safety Communication here and below: https://lnkd.in/etnhxy_X Review the updated Prescribing information when available: www.fda.gov/drugsatfda.

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    The World Health Organization (WHO) predicts over 35 million new global cancer cases in 2050. That’s a 77% increase from the estimated 20 million cases in 2022. The FDA Oncology Center of Excellence recently began Project Connect to link patients everywhere with OCE’s efforts to increase participation in cancer clinical trials. Join a Conversation on Cancer on February 11, 2025, to learn about this initiative and advance cancer care globally. Register now to receive YouTube livestream link - watch anytime after the event begins, at your convenience: https://lnkd.in/efxNRUPC #OCEProjectConnect #CancerAwareness #ConversationsOnCancer

    • Promotional image for an event by the FDA Oncology Center of Excellence and the European Medicines Agency titled 'Conversations on Cancer: Introducing Project Connect'. The event is scheduled for Tuesday, February 11th, 2025, from 10:00-11:00 AM EST and 16:00-17:00 PM CET, and will be held virtually. The background features a ribbon design interspersed with portraits of diverse individuals, symbolizing a worldwide forum for patients with cancer.
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    FDA issued a draft guidance, "Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology." This guidance focuses on drugs and biologics intended to prevent or treat chemotherapy-induced peripheral neuropathy (CIPN) in oncology patients. Drug development programs for CIPN should account for potential concerns of diminished efficacy of cancer treatment or the promotion of tumor growth. Download document or submit comments: https://lnkd.in/ezyDnRxA

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    In 2024, the FDA’s Center for Devices and Radiological Health (CDRH) took significant actions to protect and promote the public health and improve device safety, while fostering the development of medical devices that address unmet needs and provide a significant benefit to patients in the U.S. Read CDRH’s 2024 Annual Report to learn more: https://lnkd.in/eFKtaYV9

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