As a consequence of the FDA Reauthorization Act of 2017, a draft guidance about competitive generic therapy (CGT) is published with the aim to incentivize generic competition in USA. The designation of medicine as CGT, the request for designation, the expedited review and the 180 days exclusivity period are explained in this draft guideline (rev.1). Although improvements and clarifications can certainly be made to the current version, it certainly makes medicines more affordable as part of their overall sustainability.
