ALS-ETF, since 2012 the subject matter experts for ethical, feasible, and regulation- compliant Expanded Access Programs in the U.S.
What you need to know about Expanded Access
Expanded Access in Breakthrough Diseases
Dear Friends,
If you missed the
October 5th informational webinar on Expanded Access,
the re-play is here! In partnership with ALS Association, we continue to educate industry, physicians, our own community, and the public on the critical topic of early access to investigational medicines.
Our webinar explained the difference between "Right To Try" campaigns and FDA-authorized Expanded Access. We introduced the Treatment IND & Intermediate-Size IND to those whose exposure to this topic is limited to single-patient "compassionate use" requests. And we dissected some of the common narratives that have brought undue controversy to this area.
The two-day event, jointly presented by NYU School of Medicine and the New York Academy of Sciences, is designed to provoke debate and discussion around the complex issues surrounding compassionate use of medicines for critically ill patients. agenda topics Include:
Perspectives from Patient Advocates on Compassionate Use and Expanded Access
The Case of Josh Hardy and Social Media's Impact
Lessons Learned From the Ebola Virus Epidemic on Compassionate Use During a Crisis
Key Issues from Stakeholders' Perspectives, Considering a Compassionate Use Request
Legislative or Regulatory Changes on Compassionate Use and Expanded Access