The FDA also sent Congress its proposal for the traditional prescription drug user-fee program, which is expected to raise more than $712.8 million in fees annually over five years.

According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...

President Donald Trump’s proposal to increase FDA user fees is already drawing some reaction from an industry that wants to cooperate, but is blanching at a proposal that would dramatically ...

Higher user fees would increase regulatory barriers to market, added Michael H. Cohen, an FDA attorney in Palo Alto, California, but a shift in the way the FDA regulates digital health could ease ...

The ‘skinny’ user fee reauthorization tables multiple high-profile proposals. As expected, Congress reauthorized four key user fee programs last week, as part of a must-pass measure to fund the ...

FDA has at last began formal implementation of the Biologics Price Competition and Innovation Act of 2009 ("BPCI Act"), by announcing the proposal it will send to Congress to implement user fees ...

On May 11, the Senate Committee on Health, Education, Labor and Pensions marked up the proposed FDA user fee reauthorization bill and voted 21-2 to advance it to the full Senate. The bill would ...

As is typical with the FDA, the Agency chose the end of the year to publish the fees it intended to ‎collect from over-the ... Surprise” OTC User Fee and ‎Proposals for FY 2021. Wasim ...

E&C PANEL TO MARK UP USER FEE PACKAGE — The House Energy and Commerce Health Subcommittee announced Monday it will mark up bipartisan legislation, H.R. 7667, to reauthorize FDA’s medical ...

In this post, I review key provisions in the newly released bills and consider their implications for FDA. The user fee programs were last reauthorized in 2017 and are set to expire unless ...

Proposal would expand FDA oversight, keep user fees . Haymarket Media. July 20, 2007 ...

WASHINGTON — The Food and Drug Administration would collect hundreds of millions of dollars in new fees from pharmaceutical ... The user fee proposal is one of three such agreements that the ...