Hot Topics in Expanded Access Programs
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.
- 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.