Tag: ANDA

FDA Announces Measures to Speed Up Revie

Amid all the ongoing Tariff Turf War, the U.S. Food and Drug Administration (FDA) has

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