Appropriation Veto Threat Centers On Opioid Language In FDA Budget
This article was originally published in The Tan Sheet
Executive Summary
The White House likely is concerned about the potential precedent from a provision in the House bill that would link FDA funding to release of guidance. OMB says it opposes provisions that “unduly interfere” with the FDA rulemaking process.
You may also be interested in...
Compassionate Use Study Added To House Approps Orders
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.
Shutdown Week Two: Could Sponsors Find A More Focused FDA?
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.
Mary Beth Clarke, CDER Exec Programs Office Director And Generic User Fee Shepherd, Will Retire
Clarke helped launch GDUFA I and negotiate GDUFA II, chaired the CDER Executive Committee and oversaw many other programs in the US FDA’s drugs center.