Webinar Sign-Up: Expanded Access Expectations of 21st Century Cures Act

Impact, obligations, and implications of new legislative requirements

Tuesday, February 7, 2017

12:00 – 12:30 pm


The webinar will address questions such as:

  • What are the new 21st Century Cures Act requirements regarding expanded access?/li>
  • What medical products are covered by the 21st Century Cures Act?
  • What are the internal and external factors that should be considered when creating expanded access policies?
  • What are the ethical considerations?

The 21st Century Cures Act was signed into law on December 13, 2016. It is a large bill with many provisions, among them some that require specific actions from drug and device manufacturers regarding expanded access policies and communications.

This brief seminar will address those requirements and describe what is considered best practice in this new environment.


Jane RC

Jane Reese-Coulbourne, MS ChE
Senior consultant, MK&A

Alison Bateman-House, PhD, MPH, MA
Assistant professor, Division of Medical Ethics,
NYU Langone Medical Center


MK&A has extensive experience counseling companies on the development and implementation of pre-approval access programs. This work includes aiding companies in the development of an ethical and compliant strategy, and tailored policies and procedures that reflect the objectives and capabilities of individual companies. NYU School of Medicine has done extensive research in the areas of Compassionate Use and Pre-Approval Access and has broad expertise in this area.