Sources: FDA Urged LDT Working Group To Scrap Pieces Of Revised Draft Legislative Plan

October 15, 2015 at 5:55 PM
FDA officials advised a working group of large manufacturers and reference labs in their development of a revised draft proposal to regulate laboratory developed tests, highlighting areas of concern, some of which remain in the updated version, lobbyist sources told Inside Health Policy . FDA, which is not backing the plan, advised the group to, among other suggestions, drop a grandfathering provision and also questioned how they would pay for a separate in vitro center, a must have for the...

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