Warning letters, 483s, Recalls, Import Alerts, Audit observations
Hospira Inc., a Pfizer company announced recall of several injectable products in US for potential
FDA has updated MAPP for assessment of requests for reclassification of facility-based major complete response
The letter to FDA was written by the Republican members of the E&C committee of
China’s revision of counter espionage laws in April 2023, with enumeration of espionage activities extended
The GMP/GDP Inspectors Working Group coordinated by EMA has decided to continue the extension of
The European Commission has published the first Union list of critical medicines, together with the
MHRA has decided to continue the extension of the validity GMP & GDP Certificates until
The revised monograph for Propylene Glycol (PG) includes test for Ethylene Glycol (EG) and Diethylene
Baxter recalled several lots of Ondansetron injections in US for pH failure in November 2023.
FDA has approved Novartis’ Iptacopan (Fabhalta) for treatment of rare blood disease, Paroxysmal Nocturnal Hemoglobinuria
