Competitive Generic Therapies (CGT) - FDA Requirements
We are delighted to see your interest in Freyr’s Webinar Series (FWS). The webinar on, “Competitive Generic Therapies (CGT) – FDA Requirements”, was successfully concluded on November 4, 2020. Here is the archived session for your perusal.
In a nutshell, during the webinar, the presenter of the webinar, Nandakumar Reddy Gollapalli (General Manager – Global Regulatory Affairs), discussed about:
Introduction to Competitive Generic Therapies (CGT)
CGT – Why & Necessity
Criteria and Timelines for CGT Designation
Contents of Request for CGT Designation
Expedited Development and Review – Key Considerations
CGT exclusivity Vs 180-day Patent Challenge Exclusivity
Notification to FDA of First Commercial Marketing
Benefits to Industry
As a continuous practice, Freyr is destined to organize more webinar sessions related to Regulatory aspects of Life Sciences. We are sure you would like to be a part of all those sessions. If yes, we will be very much happy to inform you about the next session.