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. During this webinar, our speakers discussed the following topics:
- the current US legal framework for the most common types of compassionate use programs;
- compliance and enforcement considerations relevant to pre-approval access; and
- best practices for legal, compliance, and regulatory staff working on these issues.