Final Guidance on Competitive Generics Therapy (CGT): Opportunity to benefit from 180-day market exclusivity
About the Webinar:
US-FDA published new regulations on Competitive Generic Therapy in March 2020 for generic companies- a new pathway defined by FDA to designate drug with inadequate generic competition as CGT. This regulation is imposed to support timely access of high quality affordable generic medicines which have limited market and difficult to develop. This act provides companies with a 180- day exclusivity, different from 180-day patent challenge exclusivity, for the first approved applicant of a drug with a CGT designation.
Register for our upcoming webinar to learn more about:
Regulatory framework and expectations from regulators for generic companies
How exclusivity works?
Procedure for application for CGT
Applicability of exclusivity and how will it affect the generic companies
About the speaker:
Mona holds master’s degree in Pharmaceutics (Formulation Development) and has around 16 years of experience in Regulatory Affairs (US, Canada, EU, Russia and CIS countries) and regulatory compliance across drug products (solid orals and sterile) and medical-devices.
She brings in a lot of expertise and knowledge from her previous organizations such as Sentiss Pharma Pvt Ltd, Ranbaxy Laboratories Limited, Wyeth Pharmaceuticals (USA), Merck (USA), and Dr Reddy’s Laboratories.
Who should attend?
Professionals from the Business development team and strategic groups, R&D teams ,Regulatory Affairs professionals and consultants.