Upcoming negotiations to reauthorize the US Food and Drug Administration’s prescription drug user fee program should be viewed as a chance to make the program more efficient in the face of an administration and Congress that are looking to cut funding, lobbyists said.
Could PDUFA VIII Align With Trump’s Efficiency Emphasis?
Given the Trump Administration’s intense focus on cutting costs and increasing efficiency, industry and the FDA should focus on what is and is not working in PDUFA VII when negotiating the next agreement, lobbyists said at the BIO CEO and Investor Conference.
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Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.
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