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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Federal Right to Try Act), signed into law on May 30, creates a federal framework for patients to access investigational new drugs without enrolling in clinical trials and without FDA expanded access approval. The law, however, leaves a number of unanswered questions that industry, healthcare providers, and patients must currently navigate without the benefit of regulatory guidance. For example, exactly how the Federal Right to Try Act interacts with state right to try legislation and FDA’s existing expanded access program is currently unclear. Implementation of the Federal Right to Try Act will be a developing area that stakeholders should continue to monitor. Moreover, stakeholders considering providing investigational drug access outside of clinical trials will have a number of areas to think about when determining which pathway to use.

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