Qualification process for drug development tools: guidance for industry and FDA staff

Qualification process for drug development tools: guidance for industry and FDA staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Language(s):
English
Format:
Text
Subject(s):
Drug Approval
Drug Development -- methods
Drug Development -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
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 guidance meets the Cures Act’s mandate to issue final guidance on the section 507 qualification process. Specifically, this guidance represents the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current thinking on implementation of section 507 of the FD&C Act with respect to describing the process for requestors interested in qualifying DDTs and on taxonomy for biomarkers and other DDTs. This guidance does not address evidentiary standards or performance criteria for purposes of DDT qualification, nor does it address qualifying medical device development tools (MDDTs) through the Center for Devices and Radiological Health (CDRH). These topics will be discussed in other guidances and materials available on FDA’s DDT programs’ and MDDT program’s web pages, respectively.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (19 pages)).
NLM Unique ID:
9918249007706676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918249007706676