Aspects of generic product development from Raveendra Pai, Glenmark, Mumbai

March 22, 2017

Dr Raveendra Pai spoke at length about “Generic product development and filing: What has changed in FDA expectations?” A very relevant topic to the current context in pharmaceutical industry which the students need to know. Not only did Dr Pai brief upon the process of filing for generic product with USFDA, but also drew attention towards recent requirement, viz., Generic Drug User Fee Amendments (GDUFA). Under GDUFA II, it is anticipated that affiliated companies will come under a single umbrella for assessing the program fee. A fruitful deliberation followed with inquisitive minds regarding generic product development, procurement of RLD and industry plans for generic growth. Department of Pharmaceutics organized the guest lecture on 18 March, 2017 at Prof P Gundu Rao Conference Hall, MCOPS, Manipal.