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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.

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

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_XReview the updated Prescribing information when available: www.fda.gov/drugsatfda.
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
During Cervical Cancer Awareness Month, it’s vital to highlight not only prevention but also the importance of equitable access to treatment options. Biosimilars are transforming the healthcare landscape. For patients undergoing cancer treatment, this can mean more treatment options. Learn more: https://bit.ly/3Dbj22V #CervicalCancerAwareness
Join us as we say farewell to the second person to ever serve as FDA Commissioner twice, Dr. Robert M. Califf. Thank you, Dr. Califf, for your leadership in promoting and protecting public health!
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
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
Exciting News from the FDA! We’re thrilled to announce the release of the refreshed FDA IT Operating Plan, a key companion to the FDA IT Strategy for FY 2024 – FY 2027. This plan lays a clear roadmap to modernize the FDA’s technology landscape, optimize resources, and foster global collaboration, supporting our mission to protect and promote public health. Highlights include: ➡ A detailed IT roadmap to achieve strategic goals ➡ Enhanced governance frameworks for improved decision-making ➡ A stronger focus on global partnerships and standards This plan reflects a collaborative effort between the Office of Digital Transformation, FDA Centers, and Offices, and together with the IT Strategy, it guides our work to leverage emerging technologies, enhance data sharing, and build a resilient, secure, and globally connected IT ecosystem: https://lnkd.in/egsiA34e
FDA is warning HCPs not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC, in Largo, Fla., and Endo USA, in Malvern, Pa. HCPs have confused these products with FDA-approved injectable epinephrine products for intravenous use. The nasal solution and injectable products have similar packaging and containers and are manufactured by the same companies. The similarities of the bottle and packaging labels between the nasal product and the sterile injectable make it difficult to distinguish them from each other which can lead to HCPs accidentally injecting the nasal solution instead of the injection product. Unlike an injectable drug, nasal solutions are not required to be sterile. Injecting a non-sterile drug can lead to infection, which can be life threatening for certain patients. Learn more: https://lnkd.in/eDrbf975

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