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Last updated 3 days ago
3 days ago
This page contains the PCAC roster, which lists the current members and...
3 days ago
CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation...
3 days ago
This page contains the Nonprescription Drugs Advisory Committee Roster, which lists the...
3 days ago
Canton, SD, Jarman’s Midwest Cleaning Systems, Inc. is voluntarily recalling all lots...
3 days ago
FDA created the Rare Disease Innovation Hub (the Hub) to serve as...
3 days ago
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
3 days ago
FDA does not issue approval announcements for every approval or drug label...
3 days ago
On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda...
4 days ago
GDUFA III includes several enhancements to the ANDA assessment process to maximize...
4 days ago
FDA would like to assist sponsors and applicants who have not previously...
4 days ago
Learn more about FDA's process to validate sample new eCTD v4.0 submissions...
4 days ago
This page provides information about the electronic submission of regulatory information to...