Diagnostics Regulation Provisions Not In Second Cures Draft

May 1, 2015 at 1:00 PM
House lawmakers diverged from their earlier plan to update regulations surrounding diagnostics, with the second draft of their Cures bill instead directing FDA to clarify when test-makers can seek waivers exempting their products from certain laboratory requirements. Lawmakers had put a diagnostics "placeholder" in the first draft of the Cures bill intended to be filled in if stakeholders could forge a consensus on the hot-button regulatory issue. The second draft of the bill , unveiled by the House Energy and...


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