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.
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The agency's website soon could include petitions' status in the process, potentially providing some solace to affected sponsors. FDA dockets management staff members are preparing to add live status updates and a listing of all pending citizen petitions to the website.
Agency website soon will include where petitions are in the process, potentially providing some solace to affected sponsors.
Amended bill passes full House Energy and Commerce Committee unanimously with another $550 million in appropriations for FDA.