Model-Informed Drug Development Paired Meeting Program
FDA is conducting a MIDD Pilot Program to facilitate the development and application of exposure-based, biological, and statistical models derived…
MIDD Paired Meeting Program Frequently Asked Questions
MIDD Pilot Program Frequently Asked Questions (FAQs)
Harnessing the Potential of Artificial Intelligence
At the FDA, we’ve been working for years to anticipate and prepare for the challenges of Artificial Intelligence (AI), and…
Over-The-Counter Monograph Drug User Fee Program (OMUFA)
A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional…
Completed BsUFA III Deliverables
Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in…
GDUFA Type II API DMF Payment Receipts Report
GDUFA Type II API DMF Payment Receipts Report
October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee – 10/29/2024
This meeting is scheduled to start at approximately 8 a.m. Eastern Time and will be held at FDA White Oak…
Aztreonam and Avibactam Injection
Aztreonam and Avibactam Injection
Notice of Updates
Webpage providing notices of updates to FDA’s STIC webpages for antibacterial and antifungal drugs.
Public Meeting on the Recommendations for the Over-the-Counter Monograph Drug User Fee Program (OMUFA) Reauthorization – 11/20/2024 – 11/20/2024
The Food and Drug Administration (FDA or Agency) is announcing a hybrid public meeting to discuss proposed recommendations for the…