FDA Finalizes Guidance on Competitive Generic Therapies

Regulatory NewsRegulatory News
| 13 March 2020 | By Michael Mezher 

The US Food and Drug Administration (FDA) on Friday finalized its guidance on its designation process and criteria for competitive generic therapies (CGTs).
The CGT designation was established under the FDA Reauthorization Act of 2017 (FDARA) and is meant to incentivize the development of generics for drugs that lack competition.
The 20-page final guidance largely mirrors the draft version released in February 2019 and includes several clarifications about the CGT program and its exclusivity provisions.
“[CGT] designation has been a significant advancement in helping to bolster generic drug competition in the US,” said FDA Commissioner Stephen Hahn, noting that the agency has received more than 350 CGT requests.
In a change from the draft version, the final guidance clarifies that individual applicants should request CGT designation for each individual application. “FDA does not interpret CGT designation to automatically apply to all applications for such drug, and CGT designation therefore should be requested for each application,” FDA writes.
The final guidance further clarifies that while the agency may expedite the development of an application with CGT designation and “strive to act” ahead of the Generic Drug User Fee Amendments (GDUFA) goal date, CGT designation does not guarantees a shorter review time.
FDA also explains that both complex and non-complex generic drugs may qualify for pre-ANDA meetings on a case-by-case basis. While the meetings are meant to expedite development, FDA says it won’t necessarily expedite the meetings themselves.
Additionally, FDA says it has updated the terminology used in the final guidance “to further delineate 180-day patent exclusivity from 180-day CGT exclusivity” and made editorial changes to “clarify the operation of 180-day CGT exclusivity and forfeiture.”


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