Warning letters, 483s, Recalls, Import Alerts, Audit observations
Gilead announced FDAs approval of Livdelzi (Seladelpar) for treatment of PBC, a rare, chronic, autoimmune
The USFDA has announced the fiscal year (FY) 2025 rates for GDUFA III fees. The
South Korean Drug Regulator MFDS imposed administrative penalties on GlaxoSmithKline (GSK), reports Korea Bio Medical
Zydus Pharmaceuticals (USA) Inc initiated recall of multiple lots of Verapamil Hydrochloride injection due to
CDSCO has published list of drugs which were found to be not of standard quality
Cipla facility at Verna, Goa was audited by USFDA during June 2024 ending with issuance
Glenmark Pharmaceuticals is recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10
FDA has issued final guidance on Circumstances that constitute Delaying, Denying, Limiting, or Refusing a
USFDA 483 issued to Dr.Reddys (DRL) API unit in Pydibhimavaram, India cites failure to validate
EDQM has published the draft guideline on Content of the dossier for sterile substances for
