Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA has eliminated the REMS for Lotronex (alosetron hydrochloride) and approved generics. Alosetron hydrochloride is
USFDA has announced funding opportunity for FDA Orphan Products Clinical Trials Grant Program. The deadline
Bottles of Digoxin Tablets, USP 0.125mg are incorrectly labelled and contain Digoxin Tablets USP, 0.25mg
Flunixin meglumine is a potent, non-narcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It
As per the GDUFA III commitment letter, USFDA has issued a draft guidance for facilities
The USFDA Warning letter to K. C. Pharmaceuticals issued in August 2023, following inspection at
In a Class III recall in US, Alembic recalled 82400 bottles of Tobramycin 0.3%, Ophthalmic
Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS). Aurobindo
Biocon Malaysia was inspected by USFDA Investigators Eileen A. Liu, Patty P. Kaewussdangkul, Daniel Lahar,
Several manufacturers of OTC drug products including mouthwash, toothpaste, topical analgesics, Sunscreen products, Hand Sanitizers
