FDA’s Funding Bridle: House Demands Opioid Guidance, Limits Compounding Boost
This article was originally published in The Pink Sheet Daily
Senate appears on track to fund agency without serious caveats, setting up a potentially contentious conference.
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Republicans on the Senate HELP Committee say they are concerned that FDA is using draft guidance documents to set substantive policy, which they argue puts companies in a difficult position.
Draft guidance on abuse-deterrent opioids notes that labeling claims may be revised if abusers outwit the abuse-resistant technology; the agency’s evaluation of generic-related citizen petitions continues.
Government Accountability Office also finds that US FDA review divisions are largely consistent in their assessment times after controlling for goal dates and expedited programs.