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# Attorneys’ 4 Predictions for FDA in 2016
- URL: https://www.fdaweb.com/attorneys-4-predictions-for-fda-in-2016/
- Published: 2016-01-13T12:00:00.000Z
- Updated: 2026-09-15T02:27:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134420

> Several Wilson Sonsini attorneys say they expect FDA to begin regulating high-risk laboratory-developed tests (LDTs) early this year. Writing in an online blog [post](https://www.wsgr.com/PDFSearch/law360-0116.pdf?ref=fdaweb.com), they say this move will be contentious and that they expect court challenges to the agency’s regulation. “FDA’s regulation of LDTs has the potential to reshape a significant portion of diagnostic testing industry landscape,” they say.  
>  
> After reviewing key FDA developments in 2015, the attorneys make three additional predictions for 2016:  
> Congress may grant regulatory exclusivities to diagnostic tests, which are the cornerstone of personalized medicine; FDA, along with the Justice Department and state attorneys general, will continue enforcement actions against companies, with an increased focus on individuals, including CEOs of regulated companies; and orphan drug approvals will continue to increase.