Regulatory Process

Learn more about the process behind regulators’ evaluation of new treatments and what can be done to improve their capacity and practices to support innovative drug development.

Featured Items

FDA Draft Guidance on Duchenne

Source: Parent Project Muscular Dystrophy

PPMD report
Putting patients first

Source: Parent Project Muscular Dystrophy

FDA slide
02/19/2014
FDA's Patient-Focused Drug Development Initiative and the Benefit-Risk Assessment Framework

Tools you can use

FDA Draft Guidance on Duchenne

Source: Parent Project Muscular Dystrophy

Publications & Events

OJRD journal article
How a patient advocacy group developed the first proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration

Source: Orphanet Journal of Rare Diseases

BIO Lifecycle Assessment
Lifecycle Approach to FDA’s Structured Benefit-Risk Assessment

Source: Biotechnology Innovation Organization (BIO)

PPMD report
Putting patients first

Source: Parent Project Muscular Dystrophy

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Measuring What Matters to Patients: Innovations in Integrating the Patient Experience into Development of Meaningful Performance Measures

Webinars

slides from Lung MAP Webinar
06/18/2014
The Lung Cancer Master Protocol (Lung-MAP): A re-vamp of the clinical trials system?
FDA slide
02/19/2014
FDA's Patient-Focused Drug Development Initiative and the Benefit-Risk Assessment Framework
Engaging with FDA slide
04/18/2012
Engaging with FDA: A guide for foundation funders of research

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