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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.
As precision medicine gains momentum and in vitro diagnostics (IVDs) become increasingly used in clinical trials, pharmaceutical and biotechnology companies must quickly become familiar with the FDA’s investigational device framework.