U.S. Food and Drug Administration (FDA)

The Food and Drug Administration (FDA), also known as USFDA, is a key federal agency under the Department of Health and Human Services in the United States government. Its main role is to safeguard and enhance public health by overseeing various areas such as food safety, tobacco products, dietary supplements, prescription and over-the-counter medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, devices that emit electromagnetic radiation, cosmetics, animal food and feed, as well as veterinary products. Notably, in 2017, around 75% of the FDA's budget, which is about $700 million, came from pharmaceutical companies, thanks to the Prescription Drug User Fee Act.

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FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People | FDA

3 weeks ago | fda.gov

The U.S. Food and Drug Administration (FDA) today launched Elsa, a generative Artificial Intelligence (AI) tool designed to help employees—from scientific reviewers to investigators—work more efficiently.
FDA’s Nutrition Initiatives | FDA

1 month ago | fda.gov

FDA is prioritizing its nutrition initiatives to ensure people in the United States have greater access to healthier foods and nutrition information we can all use to make healthier choices more easily.
Tianeptine Products Linked to Serious Harm, Overdoses, Death | FDA

1 month ago | fda.gov

Tianeptine is not approved by the FDA for any medical use. Some companies are illegally marketing and selling tianeptine products and making dangerous and unproven claims that tianeptine can improve brain function and treat anxiety, depression, pain, opioid use disorder, and other conditions.
What Women Need to Know About Their Pelvic Floor | FDA

1 month ago | fda.gov

FDA Office of Women's Health Blog Sharing News on Women's Health
FDA warns consumers not to purchase or use any tianeptine product due to serious risks | FDA

1 month ago | fda.gov

FDA is warning consumers to not purchase or use any product with tianeptine.
FDA Intends to Extend Compliance Date for Food Traceability Rule | FDA

Mar 20, 2025 | fda.gov

The FDA is announcing its intention to extend the compliance date for the Food Traceability Rule by 30 months.
FDA Completes Pre-Market Consultation for Human Food Made with Cultured Pork Fat Cells | FDA

Mar 7, 2025 | fda.gov

FDA has no questions about Mission Barn’s conclusion that food made with cultured pork fat cells resulting from the production process defined in the pre-market consultation are safe
Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus | FDA

Mar 5, 2025 | fda.gov

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative | FDA

Mar 3, 2025 | fda.gov

CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
Endovascular System Recall: Philips Removes and Discontinues Distribution of Tack Endovascular System Due to User Challenges That Caused Additional Procedures to Reposition or Remove Implant | FDA

Mar 3, 2025 | fda.gov

Tack Endovascular System is used to repair artery dissection after angioplasty but ongoing user issues led Philips to discontinue use and distribution.