Food and Drug Law Institute: Regenerative Medicine Conference: Regulatory, Enforcement, and Legal Challenges for Cell and Gene Therapies

Despite gene and cell therapies' many practical differences, several regulatory pre- and post-approval considerations intersect for these therapies.

This session explored these intersections, which include trends in expedited development and approval programs for regenerative medicine therapy; novel clinical trial design challenges; conducting comparability studies; FDA's interpretation of "sameness" for orphan drug exclusivity; manufacturing, distribution, and tracking issues; and FDA's capacity to review and support the increasing volume of regenerative medicine submissions.

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