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

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.

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

Although the proposed budget stated that adding $1 billion in user fees would bring “medical product user fees to over $2 billion in 2018,” the FDA already generated (PDF) more than $2 billion ...

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 ...

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 ...

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 ...

1. Will the FDA really run out of money and shut its doors? “It would be unheard of for Congress not to pass some kind of continuing resolution if they're not going to do the full [user fees ...

As FDA kicked off the drug user fee reauthorization process, Commissioner Marty Makary said he’d like to see lower fees paid ...

It would make significant changes in FDA programs and operations, including policies for how FDA regulates diagnostics, dietary supplements, and cosmetics. Also off the table is the proposed Cures 2.0 ...

Drug and device makers pay user fees to the FDA to help speed up product reviews, and in exchange, the agency agrees to meet specific performance goals. Tags Congress fda Patty Murray Richard Burr ...

Over the program's life, she said fees have risen 600% and staff at FDA’s Center for Veterinary Medicine has also increased, yet the workload has declined by 12% and the number of products ...