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Last updated about 21 hours ago

Quality Metrics for Drug Manufacturing

about 21 hours ago

Quality Metrics Data Reporting: This program will help FDA to address common...

FDA Small Business Regulatory Education for Industry (REdI) Conference “Focus on CGMPs and FDA Inspections” Summer 2015 Presentation Slides

2 days ago

FDA Small Business Regulatory Education for Industry (REdI) Conference “Focus on CGMPs...

FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary

2 days ago

FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary

FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary

2 days ago

FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary

FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary

2 days ago

FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary

GDUFA IV: Fiscal Years 2028 – 2032

2 days ago

Information related to FDA’s preparation for the fourth reauthorization of GDUFA will...

Generic Drug User Fee Amendments

2 days ago

This page features news and information for industry and stakeholders about GDUFA...

Generic Drugs Program Monthly and Quarterly Activities Report

2 days ago

Monthly and quarterly metrics of the FDA Generic Drugs Program.

Division of Pediatric and Maternal Health - Selected Presentations

2 days ago

Division of Pediatric and Maternal Health - Selected Presentations

Generic Drug Facilities, Sites and Organization Lists

2 days ago

Generic Drug Facilities, Sites and Organization Lists

MD Pharmaceutical Supply, LLC - 637815 - 04/13/2026

2 days ago

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

MD Pharmaceutical Supply, LLC - 637815 - 11/22/2022

2 days ago

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated