New Opioids: FDA Should Ditch 'Product-Specific Approach,' Science Report Says
FDA-commissioned study recommends agency consider things like off-label use and risks of transition to illicit drugs in opioid approval decisions; opposes restricting market to abuse deterrent formulations.
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Beyond Individual Patients: FDA Emphasizes Public Health Role In Certain Benefit-Risk Decisions
US FDA’s new draft guidance on benefit-risk assessments for new drugs highlights cases where it can take into account broader public health implications than just the pros and cons calculus for the patients described in a drug's label. While not a new policy perse, it is one the agency seems to have only grudgingly employed in the past.
Pain/Addiction Products Need Regulatory Streamlining To Incentivize Development, Sponsors Say
Industry speakers offer series of suggestions for ways to incentivize development of pain and addiction products at US FDA public meeting on the opioid crisis.
Opioids: FDA Actions May Silence Call For Moratorium On Approvals
Citizen petition seeks review of all marketed opioids; agency is considering whether new opioids should have comparative benefit over existing drugs.