Citizen Petitions Seeking To Delay Product Approvals Continue To Swamp FDA
This article was originally published in The Pink Sheet Daily
Agency's latest report to Congress highlights resource burden, implies legislative fix may better discourage frivolous petitions.
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FDA worries about diverting resources to respond to 505(q) petitions, despite receiving lowest number in fiscal year 2015 since it began tracking requests.
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.