House Panel Plans March 2 Hearing On GDUFA, BsUFA And Generic PRV Bill

Amid concerns from House Energy & Commerce lawmakers that the Trump administration's federal firing freeze could negatively impact FDA's user fee commitments, the committee has scheduled a March 2 hearing on reauthorization of the generic and biosimilar user fee programs. The hearing will also address a closely watched bill that would create a generic priority review program as a solution to drug pricing. The BsUFA II commitment letter between FDA and industry, which was unveiled Sept. 16 , commits the...