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Last updated about 1 hour ago
GDUFA Paid Facilities List
about 1 hour ago
This list contains GDUFA facility payments received by the Agency. Data are...
Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry
about 6 hours ago
Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30...
Gastrointestinal Drugs Advisory Committee Roster
3 days ago
This page contains the Gastrointestinal roster, which lists the current members and...
Psychopharmacologic Drugs Advisory Committee Roster
3 days ago
Psychopharmacologic Drugs Advisory Committee Roster
Peripheral and Central Nervous System Drugs Advisory Committee Roster
3 days ago
This page contains the Peripheral and Central Nervous System Drugs Advisory Committee...
FDA Public Workshop: Future Needs for the Development of Interchangeable Products - 09/19/2025
3 days ago
The public meeting will be held on September 19, 2025, from 9...
Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals
4 days ago
This dataset provides a listing of all New Molecular Entities (NMEs) approved...
FDA Embraces Radical Transparency by Publishing Complete Response Letters
4 days ago
The FDA today published more than 200 decision letters, known as complete...
Institutional Review Board (IRB) Written Procedures
5 days ago
Guidance for institutions and IRBs on IRB written procedures
Compounding Quality Center of Excellence | Annual Conference - 08/25/2025
5 days ago
FDA’s Compounding Quality Center of Excellence will host its sixth Annual Conference...
Compounding Quality Center of Excellence | Annual Conference
5 days ago
Compounding Quality Center of Excellence Virtual Conference
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks
6 days ago
Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B...