This technical specifications document represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.
Similar Posts
Medical Gases — Current Good Manufacturing Practice
Pharmaceutical Quality/Manufacturing Standards (CGMP)FDA-TRACK: Prescription Drug User Fee Act Procedural Goals Summary
FDA-TRACK: Prescription Drug User Fee Act Procedural Goals SummaryUnichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling
08/27/2025– East Brunswick, NJ, Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing MeloxicamNefeteri Wellness – 709332 – 05/30/2025
Unapproved New DrugsEmerging Technology Program (ETP)
CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.Malaria: Developing Drugs for Treatment
Malaria: Developing Drugs for Treatment