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Last updated 3 days ago
Pharmacy Compounding Advisory Committee Roster
3 days ago
This page contains the PCAC roster, which lists the current members and...
CDER Manual of Policies & Procedures | MAPP
3 days ago
CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation...
Nonprescription Drugs Advisory Committee Roster
3 days ago
This page contains the Nonprescription Drugs Advisory Committee Roster, which lists the...
UPDATED: Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer & Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Due to Presence of Methanol
3 days ago
Canton, SD, Jarman’s Midwest Cleaning Systems, Inc. is voluntarily recalling all lots...
FDA Rare Disease Innovation Hub
3 days ago
FDA created the Rare Disease Innovation Hub (the Hub) to serve as...
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
3 days ago
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
Oncology (Cancer)/Hematologic Malignancies Approval Notifications
3 days ago
FDA does not issue approval announcements for every approval or drug label...
FDA approves neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma
3 days ago
On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda...
ANDA Assessment Program | GDUFA III Performance Goals and Program Enhancements
4 days ago
GDUFA III includes several enhancements to the ANDA assessment process to maximize...
Submit a Standardized Data Sample to FDA
4 days ago
FDA would like to assist sponsors and applicants who have not previously...
Submit an eCTD v4.0 or Standardized Data Sample to the FDA
4 days ago
Learn more about FDA's process to validate sample new eCTD v4.0 submissions...
Electronic Regulatory Submission and Review
4 days ago
This page provides information about the electronic submission of regulatory information to...