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 an ANDA applicant receives an initial letter from the Agency that the application has been filed for review, uncertainty remains.
Join EAS independent consultant Radhika Rajagopalan an expert in CMC packages including ANDAs, DMFs and INDs for a look at how to successfully submit ANDA applications. Get a glimpse of the process from FDA’s vantage point with Radhika’s experience as a former Quality Assessment Lead and Expert Reviewer in ANDA Stability Testing at FDA. Radhika will be joined by Priya Jambhekar who will share perspectives from the submitter’s viewpoint gained from her experiences working with small and large molecule candidates, human and veterinary drugs in a variety of therapeutic areas.