EOM 1352: Fri 7 June 2024, 11:36
Catalyst 7 July 2023, 14:52

Current Edition

Discovery Park: Wed 13 November 2024, 10:35
ramusmedical

Review Phase Assessment for ANDA Submission in US: A Regulatory Review

Today, the vast majority of drugs available for patients in the United States are generics that have gone through a rigorous system of evaluation supervised by the United States Food and Drug Administration (FDA). Pachipulusu Rajesh, Dr. Balamuralidhara V and Dr. Gangadharappa H.V at the JSS College of Pharmacy demonstrate how to submit the ANDA application as per FDA requirements, and the review phase. They also present a discussion of ANDAs and NDAs, looking at their similarities and differences.

 

Catalyst: Fri 8 November 2024, 14:16
Biosynth: Wed 13 November 2024, 10:18