Warning letters, 483s, Recalls, Import Alerts, Audit observations
As per the GDUFA III commitment letter, USFDA has issued a draft guidance for facilities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
USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry
Zurzuvae (zuranolone), the first oral medication to treat postpartum depression (PPD) in adults. PPD is a
The GDUFA fee rates show steepest increase for DMF by 21% to $94,682 from $78,293.
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