Did PDUFA V Pass Too Quickly?

The pending Supreme Court decision on the Affordable Care Act may have forced negotiators to finish quicker than they would have liked as legislators indicate some more time may have produced an agreement on track-and-trace standards; stakeholders may question whether the bill could have been improved had the deadline not been looming.

The reconciled FDA Safety and Innovation Act received mostly praise from Congress and stakeholders as it once again sailed easily through the House of Representatives.

More from United States

New US FDA Commissioner Makary Was Sworn In, Knew Of Plan to Push Out Marks, Sources Say

 

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.

Peter Marks Resigns From US FDA, Warns Kennedy Does Not Want Truth On Vaccines

 

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."

Newest HHS Staff Cuts Could Stymie CMS Health Plan Oversight

 
• By 

A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.

Oncology Center Of Excellence Deputy Directors Kluetz, Theoret Join US FDA Exodus

 

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.

More from North America