Summary of Amendments Submitted to the Rules Committee for H.R. 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018

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March 19, 2018 12:33 PM

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Pallone (NJ)

#1

SUBSTITUTE Requires FDA to issue guidance related to the agency’s use of expanded access outcomes for purposes of product approval. Provides liability protection to entities offering a product under expanded access, as long as they are in compliance with current federal law, and increases transparency in the FDA’s expanded access program.