Public Meeting on the Reauthorization of the Biosimilar User Fee Act
On This Page Date: December 3, 2025 Time: 9:00 a.m. – 12:00 p.m. ET The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal...FDA Recommendations on Ingestible Fluoride Prescription Drug Products
Read FDA’s assessment of the benefit/risk considerations regarding the use of ingestible fluoride drug products in children. View the meeting summary, download presentations and watch the meeting recording. Read the letter that FDA Commissioner Marty Makary,...Hintermann H3 TAR Has a Higher-Than-Expected Risk of Failure
Post-approval Study Data Update: October 31, 2025The FDA is providing an update on post-approval study data for the Hintermann Series H3 Total Ankle Replacement (TAR) system.As provided by the manufacturer in the final post-approval study (PAS) report for the...Postmarketing Requirements and Commitments: Searchable Database
FDA’s Postmarketing Requirements and Commitments Searchable Database provides information to the public on postmarketing requirements and commitments. This searchable database includes PMRs and 506B PMCs which are those studies and trials for clinical safety,...Vanguard Enterprises, LLC. dba Bedrock MFG Recalls Monarch Premium Kratom Powder Because of Possible Health Risk
Summary Company Announcement Date: October 30, 2025 FDA Publish Date: October 31, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Salmonella Company Name: Vanguard...All Drug Purchases Are
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