Department of Regulatory Affairs, Isazi Pharma and Techno Consultancy Private Limited, Vadodara, Gujarat, India-390007
*Corresponding author
Online Published on 15 December, 2021.
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.
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.
FDA Reauthorization Act (FDARA), FD&C Act, ANDA, Competitive Generic Therapy, Inadequate Generic Competition
