The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety.

GDUFA III Commitment Letter describes FDA meeting opportunities for Generic sponsors. For instance, Product Development Meetings and Pre-Submission Meetings are designed to facilitate the completeness of the ANDA application, with the intent of decreasing the probability of receiving a CRL.

Dr. Aloka Srinivasan will be participating in the 7th Impurities: Genotoxic, Nitrosamine & Beyond Summit as a keynote speaker.