For Immediate Release: September 24, 2024 Today, the U.S. Food and Drug Administration approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease […]

For Immediate Release: September 24, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Who We Are   The Office of Program and Regulatory Operations (OPRO) provides expertise in leading and managing compliance projects, by utilizing innovative and efficient project management […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]

The Center for Drug Evaluation and Research’s (CDER) Advanced Manufacturing Research Facility (AMRF) is a new laboratory for evaluating innovative drug manufacturing technologies and ensuring drugs […]

Summary Company Announcement Date: July 27, 2020 FDA Publish Date: July 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Methanol Company Name: […]

Public Summary The following 5 Drug Safety Communications were posted since the July 25, 2022 DSB meeting: January 19, 2024 (update to 11/22/2022 DSC): FDA adds […]

Summary Company Announcement Date: December 31, 2020 FDA Publish Date: December 31, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Burkholderia […]

Summary Company Announcement Date: December 21, 2022 FDA Publish Date: December 21, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of nitrosamine impurity, […]