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.
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New Opioids May Need Comparative Effectiveness Data For Approval
Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety data.
Time To Spare? US FDA “Opioid-Sparing” Guidance May Take Longer Than Expected
In August, it sounded like FDA was almost ready to issue guidance on “opioid-sparing” claims for acute pain treatments. After a November advisory committee meeting, that doesn’t seem to be the case.
Opioid Sparing Outcomes, Non-Opioid Alternatives To Get Spotlight From US FDA Advisory Cmte.
The advisory committee will discuss a broad range of questions on a facet of FDA's opioid strategy that has received less attention than the others.