##  [Competitive Generic Therapies (CGT) - FDA Requirements](/index%2ephp/webinars/competitive-generic-therapies-cgt-fda-requirements) 

<a>Pharmaceuticals</a>



<a>Past Webinar</a>



## **Competitive Generic Therapies (CGT) - FDA Requirements**

**The webinar was successfully concluded on**

  **November 4, 2020.**

[Download Webinar](javascript:void(0))





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 &amp; 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.