Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA has published the USFDA Form 483 issued to Novo Nordisk API manufacturing facility at
The USFDA has published a new guidance titled “Review of Drug Master Files in Advance
CDSCO has published list of sixtyseven Drugs & Medicinal products as Not of Standard Quality
CDSCO has published list of drugs declared as spurious in the month of September 2024.
Accord Healthcare Inc, US is recalling one lot of Cisplatin injection due to failed impurities.
USFDA has approved Inavolisib ((Itovebi) of Genentech in combination with palbociclib and fulvestrant, for the
The European Medicines Agency (EMA) has initiated a review of finasteride and dutasteride due to
CDSCO has published an update on the Spurious and Misbranded drugs in September 2024. Medicinal
CDSCO has published alert of list of drugs Not of Standard Quality (NSQ) identified during
FDA has issued an Updated Guidance for Control of Nitrosamines in Human Drugs in September
