Reconciling States' "Right to Try" Legislation and FDA's Expanded Access Program: Legal Issues

Therapeutic Innovation & Regulatory Science
Robyn S Shapiro

Abstract

In the past few years, a number of states have passed "Right to Try" (RTT) laws. These laws aim to facilitate access by terminally ill patients to potentially lifesaving investigational products (most commonly drugs) that are not approved for the market but have passed phase I of the Food and Drug Administration's (FDA's) clinical trial process and continue to undergo testing in clinical trials. Two other conventional ways for patients to access potentially life-prolonging investigational drugs are through a clinical trial (if the patient meets enrollment criteria) or through the FDA's expanded access program. This article discusses legal issues relating to the role of state and federal governments in expanded access to investigational drugs.

References

Jul 22, 2015·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Y Tony YangCharles Bennett
Aug 9, 2017·Cardiac Failure Review·Amam MbakwemCasmir Amadi

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Citations

Jul 1, 2017·Therapeutic Innovation & Regulatory Science·Laura L KimberlyAlison Bateman-House
Jul 1, 2017·Therapeutic Innovation & Regulatory Science·Matthew Carl Kirchoff, Jerome F Pierson
Apr 11, 2021·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Emmanuelle JacquetNicolas Albin

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