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.


What Was It All About?

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
  • 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.