Open AccessRegulatory aspects for competitive Generic Therapies in USA
Author(s) -
Himani Patel,
Iva Dhulia,
Umesh Dobariya,
Nidhi Pardeshi,
Yogesh Katariya
Publication year - 2021
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v9i2.463
Subject(s) - generic drug , competition (biology) , business , product (mathematics) , guideline , operations management , marketing , drug , medicine , engineering , pharmacology , ecology , geometry , mathematics , pathology , biology
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)