U.S. Food and Drug Administration (FDA)
Corporate/Government Newsroom
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed[4] and veterinary products. As of 2017, 3/4th of the FDA budget (approximately $700 million) is funded by the pharmaceutical companies due to the Prescription Drug User Fee Act. Source
Actions
Media Outlet details
| Scope | National |
|---|---|
| Language | English, Spanish |
| Country | United States of America |
Similarweb UVM
|
Request pricing |
Comscore UVM
|
Request pricing |
Recent Articles
Search ArticlesSodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP Ampules
This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product The FDA is aware that Elevaris Medical Devices, doing business as Spectra Medical Devices, has issued a letter to affected customers recommending certain Sodium Chloride Flush products affected by the Huons Co., Ltd. recall be removed from where they are used or sold.
FDA approves imlunestrant in combination with abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
On September 18, 2026, the Food and Drug Administration approved imlunestrant (Inluriyo) in combination with abemaciclib (Verzenio), for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. Inluriyo and Verzenio are manufactured by Eli Lilly and Company.
FDA Approves Therapy to Treat Ataxia in Patients with Ataxia-Telangiectasia, a Rare Genetic Disorder
The U.S. Food and Drug Administration has approved Aqneursa (levacetylleucine) for oral suspension to treat ataxia in adults and pediatric patients with ataxia-telangiectasia weighing at least 15 kg (about 33 pounds). Aqneursa was previously approved in 2024 to treat the neurological manifestations of Niemann-Pick disease type C. Today’s approval makes Aqneursa the first treatment approved for ataxia in patients with ataxia-telangiectasia.
Nitric Oxide Delivery System Correction: NOxBOX Updates Use Instructions for NOxBOXi Nitric Oxide Delivery System
The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The affected products and recommendations for what to do with the devices below have not changed.
Event Title FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics September 23, 2026
Event Title FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics September 23, 2026
Saratoga Potato Chips Issues Allergy Alert on Undeclared Soy in J. HIGGS Loaded Bacon and Cheddar Potato Chips
Summary Company Announcement Date: September 16, 2026 FDA Publish Date: September 18, 2026 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared soy allergen Company Name: Saratoga Potato Chips LLC Brand Name: Product Description: Product Description Loaded Bacon & Cheddar Potato Chips Company Announcement Saratoga Potato Chips of Fort Wayne, IN, is recalling two Best if USED BY codes of 7.75-ounce packages of J.
CDER Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs)
Applied Regulatory Examples When cause for concern warrants a QT prolongation assessment for anticancer pharmaceuticals hiPSC-CM studies that follow best practices can be used in place of an animal study that would be otherwise conducted to evaluate QT prolongation or proarrhythmic risk. A hiPSC-CM assay could be conducted in addition to a hERG assay. Blinova et al. Cell Rep. 2018. 24(13):3582-3592 Simpson et al. Br J Pharmacol.
New Approach Methodologies (NAMs) Database of Use Case Examples
Explore practical examples of New Approach Methodologies (NAMs) described in publicly available FDA application review materials. NAMs include a broad range of methods to support the 3Rs (Replacement, Reduction, and Refinement) of testing in animals, such as complex in vitro, 2D in vitro, in chemico and in silico studies. The database is organized around the method, so users can search for a NAM and then examine applications in which it appeared.
FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
For Immediate Release: September 17, 2026 The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A., MPS IIIA is a rare inherited disease that progressively damages the brain and nervous system, causing children to lose cognitive, language and other developmental abilities over time.
Korea Filler Experts MARCS-CMS 718706 — November 03, 2025
Recipient: Korea Filler Experts United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER November 3, 2025 Korea Filler Experts: This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.koreafillerexperts.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d),...