FDA's Opioid Programs: After Training, What's The Next Step?
Treatment guidelines may also appear in opioid labeling, and insurers seem to be taking the agency's advice, but will it be enough to satisfy Congress?
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Woodcock Highlights US FDA Opioid Plans Amid Sen. Manchin And Others’ Criticisms
The statement outlining opioid priorities in the FDA’s FY 2022 budget request comes on the heels of Sen. Manchin’s criticism of the acting commissioner and FDA opioid policy.
Drug Safety: FDA Pushes To Publicly Release REMS Assessments, Says It Will Improve Plan Design
Proposal would allow stakeholders to see data on REMS goals like provider training and the US FDA’s conclusions about their effectiveness.
US FDA Needs ‘More Streamlined’ REMS Enforcement Authority, Inspector General Says
Additional power would allow the agency to punish 'simple' REMS violations and improve administration of risk management programs, according to a new report looking at FDA's oversight of opioids.