Category: EMA

EMA To Review Finasteride and Dutasterid

The European Medicines Agency (EMA) has initiated a review of finasteride and dutasteride due to

USFDA and EMA Parallel Scientific Advice

Prospective applicants of Complex Generics (CG) can request for a joint meeting with FDA OGD

EMA Updates Nitrosamines Q&A documen

EMA updates Q&A document on N-Nitrosamines. In the Rev 16 (dated 7 July 2023) limits