FDA's new user fee renewal package should pose a significantly lighter implementation load for the agency than the previous reauthorization five years ago.The legislation should head soon to President Trump who is expected to sign it into law.
Implementing User Fees Should Be Lighter Lift For FDA This Time Around; Bill Heads To White House
The 2017 user fee reauthorization bill contains provisions that should be significantly easier for the agency to implement compared with the 2012 measure. Senate clears clean bill for president's review.

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FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.
In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.
About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department and experts questioned whether the cuts could be implemented without harming FDA’s core mission.
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About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department and experts questioned whether the cuts could be implemented without harming FDA’s core mission.
The General Services Administration’s updated list of “assets identified for accelerated disposition” does not include any buildings at the agency’s headquarters in White Oak, MD after its original list of “non-core” government properties for disposal had more than half the buildings on campus.
FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.