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FDA Draft Guidance on Duchenne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

Tools you can use

FDA Draft Guidance on Duchenne

Source: Parent Project Muscular Dystrophy


Publications & Events

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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