Warning letters, 483s, Recalls, Import Alerts, Audit observations
Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,
The European Commission (EC) revoked the conditional marketing authorization (CMA) of Advanz Pharma’s Ocaliva (obeticholic
CDSCO has published a drug alert regarding voluntary recall of Tisseel Lyo Fibrin Sealant VHS/D
CDSCO has published the NSQ (Not of Standard Quality) alert for July 2024. The list
Dr.Reddy’s laboratories Inc (DRL) has initiated recall of 50 batches of Ibuprofen tablets in US
FDA has given approval for Janssen’s New Molecular Entity Lazertinib (Lazcluze). Approval is accorded for
Latest circular issued by CDSCO on Good Distribution Practices (GDP) indicate that the guidance on
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
