According to an article in Pharmacogenomics Reporter, the new version of the draft bill "Better Evaluation and Treatment Through Essential Regulatory Reform for Patient Care Act," contains proposals that address the industry “in which molecular diagnostics are developed, marketed, and used.”
Senator Orrin Hatch (R-Utah) is developing the bill with input from personalized medicine advocates. The bill calls for a single, business-model-neutral regulatory pathway for IVD products to remove confusion over whether the FDA has the legal authority to regulate LDTs, reports the Pharmacogenomics Reporter.
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