Tag: ANDA

USFDA Issues Final Guidance for PFC For

USFDA has issued the final guidance for Pre-Submission Facility Correspondence (PFC) for prioritised generic drug

New FDA Guidance: Review of DMFs in Adva

The USFDA has published a new guidance titled “Review of Drug Master Files in Advance

USFDA Updates MAPP for Facility CR Major

FDA has updated MAPP for assessment of requests for reclassification of facility-based major complete response