LAW590A

041236

This course will trace the historical evolution of policy and practice of patient access to investigational medical products prior to approval by the Food and Drug Administration. Current US and international regulatory models for preapproval access will be described, reviewing procedural processes and payment frameworks. Key practical and ethical considerations will be analyzed from the perspectives of major stakeholders including patients and advocates, clinicians, industry representatives, and regulatory bodies. The course will examine existing and emerging challenges such as therapeutic misconception, crowdfunding, real world data collection, and novel concerns in preapproval access to gene therapies.

GRD - Regular Plus/Minus Grades A, B, C, D, E

Law

LAW490A