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Keeping you afloat amidst the rising sea of regulations

First-Of-Its-Kind Decision: Medicare Will Now Cover Certain Diagnostic Tests Utilizing Next Generation Sequencing for Cancer

As a result of the FDA-CMS Parallel Review Program, and representing a first-of-its-kind decision, the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination (NCD) on March 16, 2018 approving Medicare coverage and payment for diagnostic laboratory tests utilizing next generation sequencing, or NGS, for patients with certain types of advanced cancer. According to CMS, “NGS oncology panel test

Rare Pediatric Disease Clinical Trials Get New Lift from EMA-Inspired Gaucher Model

On December 6, 2017, FDA announced a new approach for pediatric disease drug development that the Agency believes will reduce the number of patients treated with a placebo and lead to more time-efficient product development. According to FDA Center for Drug Evaluation Director Janet Woodcock, M.D.,