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Last updated 1 day ago

Q&A on CGMP Requirements

1 day ago

Pharmaceutical Quality/Manufacturing Standards (CGMP)

mR.7 SUPER 700000 may be harmful due to hidden drug ingredients

1 day ago

The Food and Drug Administration is advising consumers not to purchase or...

FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer

1 day ago

On November 21, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda...

A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium - 02/13/2024

1 day ago

A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice &amp...

Pharmaceutical Quality Resources

1 day ago

FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance...

Expiration Dates - Questions and Answers

1 day ago

Pharmaceutical Quality Resources Expiration Dates - Questions and Answers

Questions and Answers on Quality-Related Controlled Correspondence

1 day ago

Questions and Answers on Quality-Related Controlled Correspondence

GDUFA Type II API DMF Payment Receipts Report

2 days ago

GDUFA Type II API DMF Payment Receipts Report

Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?

2 days ago

Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA? | September 19...

Pediatric Tracking Requirements Under FDAAA

2 days ago

Dissemination of pediatric information resulting from pediatric studies done pursuant to FDAAA

Executive Order 14017 on America’s Supply Chains

3 days ago

Updates on recommendations to help shore up the U.S. pharmaceutical supply chain...