Warning letters, 483s, Recalls, Import Alerts, Audit observations
The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment
Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in
FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing
The FDA has issued new guidance on “Considerations for Complying With 21 CFR 211.110.” According
Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical
USFDA is proposing to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) drug
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,
