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FDA Resends Trump-Era PMTA, SE Tobacco Rules To OMB For Review

By Beth Wang / April 6, 2021 at 2:31 PM
The White House Office of Management and Budget is again reviewing two FDA tobacco rules that were pushed out in the last days of the Trump administration but then promptly withdrawn under President Joe Biden’s regulatory freeze. One of the rules would establish application and recordkeeping requirements for premarket tobacco products and the other would set out format and content requirements for substantial equivalence reports. When FDA announced the final rules on Jan. 19 , then-FDA chief Stephen Hahn said...


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