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.
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Publications & Events
How a patient advocacy group developed the first proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration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
Lifecycle Approach to FDA’s Structured Benefit-Risk Assessment
Source: Biotechnology Innovation Organization (BIO)