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)
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