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Hot Topics in Expanded Access Programs

Tuesday, September 22, 2020
Arnold & Porter Webinar

As patient organizations and healthcare providers become more sophisticated about potential pathways to seek early or expanded access to unapproved, off-label or cost-subsidized therapies, legal and compliance teams within biopharmaceutical companies are coming under increased pressure to develop rational, compliant safeguards around compassionate use programs. We will discuss during this one-hour webinar.

Topics

  • The current US legal framework for the most common types of compassionate use programs.
  • Compliance and enforcement considerations relevant to pre-approval access.
  • Best practices for legal, compliance, and regulatory staff working on these issues.

Meet the Speakers

Mahnu V. Davar
Partner
Arnold & Porter
Matthew T. Fornataro
Counsel
Arnold & Porter
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