US FDA Changing View Of Citizen Petition Response Time, Could Eliminate Serial Refiling
By aligning petition filing deadlines with user fee goals, agency could discourage petitions that need response within 150 days, potentially ending non-substantive response practice.
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US FDA can encourage and increase competition, but cannot force generic companies to enter markets deemed unprofitable, CDER director says.
FDA worries about diverting resources to respond to 505(q) petitions, despite receiving lowest number in fiscal year 2015 since it began tracking requests.
Agency website soon will include where petitions are in the process, potentially providing some solace to affected sponsors.