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 ...

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 ...

As FDA user fee agreements make their way through Congress with largely bipartisan support, ... RELATED: Trump’s proposal to increase FDA user fees could impact small digital health innovators.

The FDA doesn’t appear to be buying the two year compromise on user fees that the medical device industry is floating in lieu of a full reauthorization of the fees med tech companies pay to 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 ...

The “skinny” user fee reauthorization dropped multiple high-profile proposals for revising how FDA regulates in vitro diagnostics, dietary supplements, and cosmetics, as well as the agency’s ...

The US Food and Drug Administration has proposed allocating an extra US$4.6 million a year to improving and expediting new drug development as part of a package of measures that would increase the ...

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 ...

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.

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 ...