CGT Archives - Lachman Consultant Services, Inc.

Calendar Year 2022 and FY 2022 CGT Approvals

By Bob Pollock Jan 24, 2023 Approvals CGT FDA Regulatory Affairs

The Office of Generic Drugs reports that it approved 64 applications that were designated for competitive generic therapy (GCT) program. Since its inception, the program has approved a total of 186 (2 thus far in 2023) applications with the GCT designation. For the 2022 FY, OGD approved 69 ANDA that had GCT designation. Remember that […]

Jan

Quarterly Reporting Requirements for Priority Review Applications and Competitive Generic Therapy Posted Today

By Bob Pollock Jan 20, 2023 ANDAs CGT FDA Generics Priority review Regulatory Affairs

As the FDA notes, “Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs with a competitive generic therapy (CGT) designation under section 506H of the FD&C […]

CGT

Calendar Year 2022 and FY 2022 CGT Approvals

Quarterly Reporting Requirements for Priority Review Applications and Competitive Generic Therapy Posted Today

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