FDA Proposed Regulation of Laboratory Developed Tests (LDTs)

Dear Colleagues,

As you may know, the FDA is considering regulating laboratory developed tests (LDTs) and had an open comment period that ended February 2, 2015.  We would like to share with you a response that we wrote from our perspective at PharmGKB, working with the Stanford Law School “IP and Innovation Clinic” directed by Prof. Phil Malone.   Several law students worked on this with us on a very tight schedule since their clinic just started in January.  We anticipate other opportunities to comment on this important issue, and would be interested if any of you filed comments that you are willing to share.  This is a confusing situation and not directly in our expertise, but we saw an opportunity to get some things about PGx on the record.

Russ & Teri

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