USA, FDA finalized its guidance on its designation process and criteria for competitive generic therapies (CGTs).
CGTs designation was created under FDA Reauthorization Act of 2017 (FDARA) with the purpose of encouraging improvement to the development of generics for drugs that lack competitiveness.
This 20-page final guidance which is similar to the draft version released in February 2019 includes additional clarifications about the CGT program and its exclusivity provisions.
The final guidance provides further clarifications on how every individual applicant should request CGT designation for each individual application.
It also states although CGT designation may expedite the development of an application, they do not guarantee or promise a shorter review time.
FDA also highlighted that both complex and non-complex generic drugs may qualify for pre-ANDA meetings on a case-by-case basis.