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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Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety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.
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.
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.