The results of our science and research often provide the generic drug industry with new methodologies and tools to help establish drug equivalence standards and support […]
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 […]
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