Summary Company Announcement Date: May 21, 2024 FDA Publish Date: May 22, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety […]

Contains Nonbinding Recommendations Do the CGMP regulations require a firm to retain the equipment status identification labels with the batch record or other file?  Assuming each […]

For Immediate Release: May 21, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Delivery Method: UPS Overnight Delivery Signature Required Product: Dietary SupplementsDrugs Recipient: Recipient Name Dr. Canh L. Duong Recipient Title Owner American Chinese Natural Herbs, Inc. 2205 […]

On This Page Date: September 14 – 15, 2021 Day1: Tue, Sep 14 11:00 AM – 5:35 PM ET Day2: Wed, Sep 15 11:00 AM – […]

Collaborating with States FDA’s compounding program closely collaborates with state officials in a variety of ways, including: sharing information about compounders who engage in poor practices […]

Effective communication among ANDA applicants, DMF holders, and FDA is essential for reducing the likelihood of potential problems that could delay approvals. The reauthorization of the […]

GDUFA Guidance for Industry To view all GDUFA guidances, go to the Guidances for Drugs page, enter “GDUFA” in the search box, and under “Filter by,” […]

5/21/2024 Drug Approval Package: JAYPIRCA 11/9/2023 First Interchangeable Exclusivity Expiration Memorandum for Cyltezo October 3, 2023 (PDF – 1.41MB) 5/15/2023 Adverse event report for Syfovre (PDF […]