Pharmaceuticals
Past Webinar

Competitive Generic Therapies (CGT) - FDA Requirements

The webinar was successfully concluded on

November 4, 2020. 

Download Webinar

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.