Warning letters, 483s, Recalls, Import Alerts, Audit observations
The letter to FDA was written by the Republican members of the E&C committee of
FDA had issued USFDA 483 in December 2022 to Novartis US site at Morris Plains,
FDA approves Evive Biotech’s Ryzneuta for the management of chemotherapy-induced neutropenia (incidence of infection, as
Cipla in a statement informed that its Pithampur, Indore facility is issued an USFDA Warning
FDA uses Remote Regulatory Assessments (RRAs) to assess compliance of facility with applicable laws and
Nectar Lifesciences was issued an Untitled letter (UL) by USFDA in Sep 23 citing deficiencies
In a communique Biocon stated USFDA has categorised inspection classification for Biocon Malaysia as OAI
USFDA announced it has awarded 10 new clinical trial studies through Orphan Products Grants Program
USFDA has eliminated the REMS for Lotronex (alosetron hydrochloride) and approved generics. Alosetron hydrochloride is
As per the GDUFA III commitment letter, USFDA has issued a draft guidance for facilities
