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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
In an attempt to minimize perceived obstacles to generic drug market entry, the FDA issued two draft guidance documents on May 31, 2018, related to shared system risk evaluation and mitigation strategies (REMS), providing the industry with insight into a previously underdefined area of FDA regulation.
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.