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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...

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...