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Regulatory Focus™ > News Articles > 2020 > 11 > FDA finalizes guidances on complex generics meetings, drug development tools

FDA finalizes guidances on complex generics meetings, drug development tools

Posted 25 November 2020 | By Kari Oakes 

FDA finalizes guidances on complex generics meetings, drug development tools

The US Food and Drug Administration (FDA) has finalized guidance for industry on the pathway for discussions about complex products. The final guidance leaves largely untouched a 2017 draft guidance developed as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II).
The guidance walks developers of complex generics through the process for scheduling formal meetings with FDA through the abbreviated new drug application (ANDA) process in a step-by-step fashion, addressing meeting types and how to request meetings at each stage of the development and submission process. (RELATED: FDA targets complex generic drugs with new draft guidance, Regulatory Focus 02 October 2017)
“This guidance reflects a unified approach to all formal meetings between FDA and ANDA applicants or prospective ANDA applicants for complex products,” said FDA in the Federal Register announcement of the final guidance’s availability.
The set of instructions meets GDUFA II goals in which FDA agreed to establish a pre-ANDA program “intended to clarify regulatory expectations for prospective applicants early in product development, assist applicants to develop more complete submissions, promote a more efficient and effective ANDA review process, and reduce the number of review cycles required to obtain ANDA approval, particularly for complex products.”
A second finalized guidance addresses the process for qualification by FDA of drug development tools. The guidance stems from Cures Act requirements for drug development tool (DDT) qualification that featured boosted transparency provisions and the establishment of a taxonomy for biomarkers used in drug and biologics development.
“Qualified DDTs can accelerate the integration of innovation, clinical knowledge, and scientific advances, thereby expediting drug development and aiding the regulatory review of applications,” said FDA in announcing the availability of the guidance.
The qualification of a DDT means it can be utilized within its context of use in support of a variety of regulatory submissions for drugs and biologics. Qualification is voluntary; a procedure specified in the Cures Act must be followed by developers who wish to submit a DDT for qualification.
In updating the 2019 draft, the final guidance clarifies details of the qualification process and gives more specific information about content elements required by individual programs. (Related: Drug development tools: FDA drafts guidance on qualification process, Regulatory Focus 13 December 2019)
Complex generics formal meetings
 DDT qualification process


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Tags: FDA

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