1. Generics Bulletin

FDA’s Final CGT Guidance Brings Clarity

CGT Designation Does Not Mean Shorter Review Time

 
• By Akriti Seth

After issuing a draft version of the guidance on the competitive generic therapy pathway meant to incentivize the development of generics for drugs that lack competition in February 2019, the US FDA has now issued the final guidance that includes several clarifications.

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FDA issues clarifications in the final CGT guidance • Source: Shutterstock

The US Food and Drug Administration has issued a finalized guidance on its designation process and criteria for competitive generic therapies. In order to bring clarity to the CGT pathway in the US, the 20-page final guidance “includes several clarifications about the CGT program and its exclusivity provisions.”

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