Qualification Process for Drug Development Tools

On 12 December 2019 the FDA announced the availability of the draft guidance for industry and FDA staff. Comments may be submitted by 7 February 2020.

Section 3011 of the 21st Century Cures Act (Cures Act) added new section 507, Qualification of Drug Development Tools (DDTs), to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This draft guidance meets the Cures Act’s mandate to issue guidance on this section-507 qualification process and related Prescription Drug User Fee Act (PDUFA) VI commitments; the draft guidance of the same name issued January 7, 2014, is withdrawn. Specifically, once finalized, this guidance will represent the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current thinking on taxonomy for biomarkers and other DDTs, and on implementation of section 507 of the FD&C Act with respect to the processes for requestors interested in qualifying DDTs.

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