Right to Try Laws vs. FDA Expanded Access: What You Need to Know and What You Need to Do | COSMOS Compliance Universe

Right to Try Laws vs. FDA Expanded Access: What You Need to Know and What You Need to Do

Paul Papagni, Executive Director of Research, Holy Cross Hospital Trinity Health.

June 2, 2020

Many states are passing laws allowing terminally ill patients access to experimental therapies that have not been approved by the Food and Drug Administration. The FDA already allows access to such drugs through Expanded Access Programs
Do you your doctors, IRB, pharmacists, compliance staff know the differences in these laws/regulations and the different processes for seeking permission to use unapproved therapies?
Know which is best for your patient, which is best for your institution, and which is more likely to be approved

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Paul Papagni, Executive Director of Research, Holy Cross Hospital Trinity Health.

June 2, 2020

Many states are passing laws allowing terminally ill patients access to experimental therapies that have not been approved by the Food and Drug Administration. The FDA already allows access to such drugs through Expanded Access Programs

Do you your doctors, IRB, pharmacists, compliance staff know the differences in these laws/regulations and the different processes for seeking permission to use unapproved therapies?

Know which is best for your patient, which is best for your institution, and which is more likely to be approved
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