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

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 ...

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 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.

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 ...

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

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 ...

Lawmakers To Release Proposals To Extend FDA’s User Fee Programs. Leaders of a House health subcommittee and Senate health committee this week are releasing the so-called "chairman's mark" of ...

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 ...

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 ...

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 ...