Warning letters, 483s, Recalls, Import Alerts, Audit observations
Strides Pharma Inc is recalling over 38 lots of Testosterone Gel 1% in the US
Health Ministry in India has extended the timeline for implementation of the revised Schedule M
The FDA has issued new guidance on “Considerations for Complying With 21 CFR 211.110.” According
The USFDA has published a new guidance titled “Review of Drug Master Files in Advance
FDA has issued an Updated Guidance for Control of Nitrosamines in Human Drugs in September
FDA has issued final guidance on Circumstances that constitute Delaying, Denying, Limiting, or Refusing a
EDQM has published the draft guideline on Content of the dossier for sterile substances for
The guidance provides information on how FDA decides goal dates for a drug application (ANDA,
The Drug Controller General of India (DCGI) has notified that effective from May 15, 2024, the issuance of
The revised EDQM guideline “Content of the dossier for chemical purity and microbiological quality of
