Abstract
The FDA Reauthorization Act (FDARA) of 2017 lets generic companies ask for expedited review and 180-day exclusivity for a Competitive Generic Therapies (CGT)-designated product. (1)
 FDA guidance for industry on Competitive Generic Therapies (CGT) provides keen information for generic drug manufacturers who want to develop a drug with inadequate generic competition. This guideline is specially published for generic players. If you are a generic manufacturer or sponsor, this will
 
 Explain the process and criteria to request and designate a drug as a CGT.
 Information on the actions FDA may take to expedite the development and review of ANDAs designated as CGT.
 Implementation of 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs. (1)
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.