Providers Still See Drawbacks To Opioid Education Mandates
Participants in a US FDA meeting on opioid REMS did not treat a move to mandatory education as a foregone conclusion. Instead, they delved frequently into alternate approaches to enhance the education itself.
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FDA Exploring Partnerships As Alternative To REMS Mandate For Opioid Education
The US FDA is continuing to think through mechanisms to make opioid prescriber education mandatory – either separate from or in addition to relying on its REMS authority.
Non-Opioid Pain Treatments Likely Not Eligible For Accelerated Approval, US FDA Says
Other expedited pathways like fast track, priority review or breakthrough could be appropriate, according to new draft guidance.
Califf Confirmation Hearing Round Two: Industry Ties Once Again May Bark Loud, Bite Lightly
The cardiologist seeking another term as FDA commissioner has been working in the pharma industry since leaving the post, but Senators have tended not to question nominee's work history extensively during previous confirmation hearings.