“Real Time” Communication During the CMC (Chemistry, Manufacturing, and Controls) Review with OPQ (Office of Pharmaceutical Quality), CDER
Join FDA and GPhA for a webinar about FDA's increased communication practices during the review of the chemistry, manufacturing, and controls (CMC) portions of all original ANDA submissions received on or after October 1, 2014. This additional communication will provide industry with a significant opportunity to respond in “real time” to regulatory comments and/or questions.
Please Click Here to register for the webinar on December 5, 2014 from 11 am to 1 pm (EST).
For more information and the latest events regarding GDUFA, please visit our Generic Drug User Fee Amendments of 2012 website.