FDA Further Explains Delay on LDT Guidance image

Regulatory Affairs Professionals Society, January 13, 2017
Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

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From the article:

Several praised the move to delay the final guidance, particularly as a new administration and Congress work with FDA and the Centers for Medicare & Medicaid Services (CMS) to come up with a new way of regulating LDTs.

Rachel Sachs, a law professor at Washington University in St. Louis, told Focus: “I have been very impressed with the collaborative spirit demonstrated by the FDA and CMS under the leadership of Commissioners [Rob] Califf and [Andy] Slavitt. The discussion in this paper of FDA/CMS collaboration is just one of many recent examples of collaboration between the agencies in ways that have potential to make the process of innovation and regulation more predictable and efficient.” [...]

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bioethics biotechnology fda health law policy pharmaceuticals rachel sachs regulation