Seaway Pharma Inc. – 717355 – 12/01/2025
CGMP/Finished Pharmaceuticals/Adulterated
CDL Services, Inc. DBA Technichem – 713877 – 11/24/2025
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc. – 715846 – 11/12/2025
CGMP/Finished Pharmaceuticals/Adulterated
Prescription-to-Nonprescription (Rx-to-OTC) Switches
A sponsor of a nonprescription drug product may seek to market a prescription drug product as nonprescription.
Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers
The guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and…
FDA Roundup: May 31, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Roundup: March 12, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Roundup: January 7, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval
The FDA converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that…
FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes
The FDA approved two medicines as additions to diet and exercise to improve blood sugar control in children 10 years…