Patient-focused drug development: collecting comprehensive and representative input : guidance for industry, Food and Drug Administration staff, and other stakeholders

Patient-focused drug development: collecting comprehensive and representative input : guidance for industry, Food and Drug Administration staff, and other stakeholders

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 Biologics Evaluation and Research (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Language(s):
English
Format:
Text
Subject(s):
Drug Development
Feedback
Sampling Studies
Patient Reported Outcome Measures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This guidance is intended to address both a statutory requirement under the 21st Century Cures Act of 2016 (hereafter referred to as "Cures Act") Section 3002 (c) and a commitment made under the Prescription Drug User Fee Act (PDUFA) VI (authorized under the FDA Reauthorization Act of 2017 (FDARA), Title I) to issue methodological guidance to support patient-focused drug development. The guidance to be issued under Cures Act section 3002(c)(1) shall address: "Methodological approaches that a person seeking to collect patient experience data for submission to, and proposed use by, the Secretary in regulatory decision making may use, that are relevant and objective and ensure that such data are accurate and representative of the intended population, including methods to collect meaningful patient input throughout the drug development process and methodological considerations for data collection, reporting, management, and analysis." In addition to this Cures Act provision, FDA committed to publish a series of guidances under Section I.J of the PDUFA VI Reauthorization Performance Goals for "Enhancing the Incorporation of the Patient's Voice in Drug Development and Decision-Making," and the first of the series (referred to as "Guidance 1") covers the same methodological topics as Cures Act sections 3002(c)(1), with the additional commitment to include standardized nomenclature and terminologies.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (iii, 41 pages)) : illustrations.
Illustrations:
Illustrations
NLM Unique ID:
9918230998606676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918230998606676