New Opioid Approval Standard Intended To Drive Development Into Other Therapeutics
US FDA explored whether existing law allowed for the higher standard, but determined new authority granted by Congress was necessary.
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Labeling changes for the pain products remain in active discussion, the US FDA commissioner tells the Senate Health, Education, Labor and Pensions Committee during a hearing on the monkeypox outbreak.
Amylyx’s ALS Drug Lacks ‘Confirmatory Evidence’ Needed To Support Approval On Single Study, FDA Says
New analyses on individual responders, survival and biomarker data are not independent evidence of AMX0035’s clinical effect in ALS, agency says in advisory committee briefing document. However, FDA’s framing of the issues, with an emphasis on regulatory flexibility and unmet medical need, could sway a favorable recommendation in its second panel review.
The Overdose Prevention Framework includes considering whether FDA should require new opioids show superior safety compared to existing products.