Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and […]

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration (FDA)’s ongoing efforts to recruit qualified experts with minimal conflicts of […]

Summary Company Announcement Date: August 26, 2020 FDA Publish Date: August 26, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains 1-propanol. Company […]

For Immediate Release: July 08, 2024 Today, the U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date […]

In fiscal year 2022, FDA’s Office of Orphan Products Development (OOPD) funded three natural history studies under the Orphan Products Grants program which serve to meet […]

Summary Company Announcement Date: June 13, 2023 FDA Publish Date: June 14, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Packaging may contain incorrect […]

Docket Number: FDA-2014-D-0447 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for […]

Docket Number: FDA-2024-D-2484 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health […]

[7-5-2024] The Food and Drug Administration is advising consumers not to purchase or use Hard Steel, a product promoted and sold for sexual enhancement on various websites, […]