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Latest From Brenda Sandburg
Latest citizen petition seeks to halt US FDA approval of Mallinckrodt's immediate release oxycodone abuse deterrent formulation; user fee action date is Nov. 16.
The agency seeks input on the types of qualifying investigations that involve minimal risk. Providing informed consent waivers in these cases, as required by the 21st Century Cures Act, will help advance health-care innovations, FDA says.
Agency seeks input on types of investigations that would involve minimal risk, exclusion of waiver to research involving identifiable private information.