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Guidance Documents/Guidance-Document/Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry

Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

June 20, 2019

May 15, 2020

Center for Drug Evaluation and Research

c20377b8-3086-48cf-be2b-b9cd12520573

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