The user-fee proposal is one of three such agreements that the agency is submitting to Congress for approval by lawmakers. The agreements would each charge drug manufacturers application fees for ...

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

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 ...

A vague and somewhat perplexing provision buried in President Donald Trump’s budget blueprint would double FDA user fees, placing a new burden on the digital health industry—particularly ...

The House has passed a bill that would expand the Food and Drug Administration's oversight of prescription drug safety and reauthorize the Prescription Drug User Fee Act, which is set to expire at ...

The current five-year Prescription Drug User Fee program expires at the end of September. It is up to Congress to reauthorize the program or risk the loss next year of about $400 million in ...

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 ...

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

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

Moving forward 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 ...

FDA keeps its user fees but fails to gain important reforms. As expected, Congress reauthorized four key user fee programs at the last moment, as part of a must-pass measure to fund the federal ...

Lawmakers this week will advance a deal to fund drug and medical device evaluations at the Food and Drug Administration (FDA) for the next five years, but without any additional policy reforms. The… ...