Overview of Device Regulation | FDA
Jan 31, 2024 · Device Advice. Overview of regulations for medical devices: premarket notifications (510 (k)), establishment registration, device listing, quality systems, labeling and …
2 MATERIAL REVIEWED Draft OPDIVO QVANTIG (nivolumab and hyaluronidase-nvhy) injection MG received on February 29, 2024, revised by the Review Division throughout the review …
Coronavirus Disease 2019 (COVID-19) | FDA
Sep 16, 2025 · The latest information on FDA-approved and FDA-authorized COVID-19 tests, treatments, and vaccines.
List of Select Chemicals in the Food Supply Under FDA Review
On August 19, 2025, the U.S. Food and Drug Administration (FDA) updated this list of select chemicals currently under the agency’s review to provide more insight on the status of the …
FDA Finalizes Updated “Healthy” Nutrient Content Claim
Feb 24, 2025 · Original Constituent Update December 19, 2024 The U.S. Food and Drug Administration today issued a final rule to update the “healthy” nutrient content claim to help …
Registered Outsourcing Facilities | FDA
Oct 30, 2025 · Find FDA-registered outsourcing facilities for safe human drug compounding, with compliance updates, quality standards, and verified facility information.
Submit final printed carton and container labeling that are identical to the enclosed carton and container labeling submitted on December 17, 2024, to BLA 761381 as soon as they are …
BMS is seeking FDA agreement on the proposed content and technical aspects of the proposed BLA. BMS plans to submit the BLA in March 2024. (b) (4) (b) (4) (b) (4) According to BMS, …
Guidance for Industry: Registration and Listing of Cosmetic …
This guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.
Medical Device Recalls
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.