Regulatory aspects for competitive Generic Therapies in USA | Zendy

Himani Patel | Zendy; Iva Dhulia | Zendy; Umesh Dobariya | Zendy; Nidhi Pardeshi | Zendy; Yogesh Katariya | Zendy

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Regulatory 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)

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