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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Tianeptine Products Linked to Serious Harm, Overdoses, Death | FDA

3 weeks 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.
FDA warns consumers not to purchase or use any tianeptine product due to serious risks | FDA

4 weeks ago | fda.gov

FDA is warning consumers to not purchase or use any product with tianeptine.
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.
Aspartame and Other Sweeteners in Food | FDA

Feb 28, 2025 | fda.gov

High-intensity sweeteners are used as sugar substitutes because they are many times sweeter than sugar but contribute only a few to no calories.
Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse due to High Rate of Stroke or Transient Ischemic Attack | FDA

Feb 28, 2025 | fda.gov

Biosense Webster updated Instructions for Use for Varipulse due to higher-than-anticipated incidence of peri-procedural stroke or transient ischemic attack.
Regard Newborn Kit Recall: ROi CPS, LLC Removes Certain Newborn Kits Due to a Recalled Component, the Neo-Tee T-Piece Resuscitator With An Undersized Controller Spring | FDA

Feb 28, 2025 | fda.gov

ROi newborn kits include Neo-Tee T-Piece Resuscitators. The Neo-Tee may have an undersized controller spring that could affect patient breathing support.
FDA Finalizes Updated “Healthy” Nutrient Content Claim | FDA

Feb 24, 2025 | fda.gov

FDA has issued a final rule to update the “healthy” nutrient content claim to help consumers identify foods that are particularly useful as the foundation of a diet that is consistent with dietary recommendations.