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…
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020 to aid…
Screening and Quantification of the Synthetic Cannabinoid Receptor Agonist 5F‐MDMB‐PINACA From Seized Prison Paper Using Ultraperformance Liquid Chromatography–Mass Spectrometry Approaches
Synthetic cannabinoid receptor agonists are being infused on paper and illicitly introduced into prisons through mail correspondence. An approach to…