Exactly 8 Friday's later, FDA released a 12-page lookback and review of its LDT regulation effort.
- For the FDA document, here.
- For a review online at RAPs, here.
- Coverage at Genomeweb (subscription), here.
The document is styled as a "discussion paper" and likely captures some of the learnings and changes in plan that occurred inside the FDA between the 2014 draft guidance and the writing of a final guidance that has been deep-sixed.