Jun 3, 2020 | Drugs, On Demand Webinar
The FDA Generic Drug User Fees Amendment (GDUFA) has entered a relatively matured stage with applicants of Abbreviated New Drug Applications (ANDAs) experiencing a timely review and communications regarding their submissions packet, as well as increasing approval numbers. However, until …
Feb 1, 2020 | EASeNews, Issue of the Month
By Radhika Rajagopalan The FDA Generic Drug User Fees Amendment (GDUFA) has entered a relatively matured stage with applicants of Abbreviated New Drug Applications (ANDAs) experiencing a timely review and communications regarding their submissions packet, as well as...
Jan 1, 2020 | Who’s Who at EAS
Radhika Rajagopalan, Ph.D. is a former Quality Assessment Lead, Expert Reviewer in ANDA Stability Testing at FDA. She has decades of experience with CMC packages including ANDAs, DMFs (Type 2 and 4), INDs, Bio-INDs, OTCs, supplemental new drug applications, novel...
