Public Citizen Challenges Trump's Regulation Executive Order
Suit claims that Trump overstepped presidential authority.
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But even though executive order that requires regulatory off sets may only have limited application to FDA, limited, experts warn that it still could prove extremely unwieldly to implement.
Executive order mandating two existing regulations be eliminated for every new one issued includes guidances, raising questions about how FDA will communicate with industry going forward.
A proposed pilot program would offer for “split submission and review” of some application sections in other disease areas. Discussions also touch on concept of a CDER-CBER RWE committee.