Warning letters, 483s, Recalls, Import Alerts, Audit observations
Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,
The USFDA has announced the fiscal year (FY) 2025 rates for GDUFA III fees. The
FDA has issued final guidance on Circumstances that constitute Delaying, Denying, Limiting, or Refusing a
The guidance provides information on how FDA decides goal dates for a drug application (ANDA,
FDA has announced the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC
USFDA has updated Safety Communication on Chinese made plastic syringes. FDA had issued a Safety
USFDA Inspectors Anders W. Evenson and Arsen Karapetyan had inspected the Sichuan Deebio facility (FEI
Prospective applicants of Complex Generics (CG) can request for a joint meeting with FDA OGD
Each Drug Establishments (Registrants*) registered with FDA must provide information on amount of each listed
The USFDA announced next phase of the Quality Management Maturity (QMM) Program for drug manufacturers.
