Bloomberg Law
April 25, 2019, 9:41 AM

Expanded White House Policy Could Stifle FDA’s Industry Advice

Jacquie Lee
Jacquie Lee

A recent White House oversight policy change could gum up the FDA’s day-to-day work and hurt industry’s ability to stay in compliance, lawyers told Bloomberg Law.

A White House memo released this month concluded the Congressional Review Act gives more discretion to its Office of Management and Budget over regulatory agencies than previously thought. The statute outlines what sorts of agency rules and documents are subject to executive branch oversight.

Among documents that will require more scrutiny are Food and Drug Administration guidance documents, which drug and device companies rely on to steer their regulatory and clinical trial compliance priorities. ...

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