FDA Veto Threat Centers On Opioid Language In Approps Bill
This article was originally published in The Pink Sheet Daily
There’s a lot the White House doesn’t like in the House agriculture spending bill, including concern about the potential precedent of the provision linking FDA funding to release of guidance.
You may also be interested in...
House Appropriations Committee wants to better understand issues with denied expanded access requests and requests Government Accountability Office study of FDA efforts in funding bill.
User-fee supported employees continue to work on pending reviews, and the lack of distractions from other tasks may help sponsors as the shutdown continues.
Draft guidance on abuse-deterrent opioids notes that labeling claims may be revised if abusers outwit the abuse-resistant technology; the agency’s evaluation of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.