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GUIDANCE DOCUMENT

Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff December 2019

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2010-D-0529
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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 This draft guidance meets the Cures Act’s mandate to issue guidance on this section-507 qualification process and related Prescription Drug User Fee Act (PDUFA) VI commitments; the draft guidance of the same name issued January 7, 2014, is withdrawn.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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2010-D-0529.

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