In:
International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 9, No. 2 ( 2021-06-15), p. 16-19
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)
Type of Medium:
Online Resource
ISSN:
2321-6794
,
2321-7162
DOI:
10.22270/ijdra.v9i2.463
Language:
Unknown
Publisher:
Society of Pharmaceutical Tecnocrats
Publication Date:
2021
detail.hit.zdb_id:
2738279-5
SSG:
15,3
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