OMB: US FDA Has Withdrawn At least 10 Regulations In Response To Trump 2-for-1 Order
Following several executive orders from the president intended to remove regulations from the federal books, the White House tells Medtech Insight it has already pulled multiple rules from FDA and other agencies – and that number may still grow by the time the Office of Management and Budget has completed an agency-wide review.
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'Major' Pain For FDA: Under OMB Directive, Congress Will Vote On So-Called 'Major' Rules, Guidance Docs
New regulations and guidance documents from the US FDA will soon have to undergo scrutiny from the Office of Management and Budget to determine whether they're "major" and should therefore be reviewed and approved by Congress. The direction from OMB acting Director Russell Vought in an April 11 memo will undoubtedly delight some in the medical device industry who have complained for years that the FDA uses voluntary guidance documents to actively drive regulatory decisions.
Among the topics US FDA Commissioner Gottlieb touched on were the agency's efforts to reduce clinical development burdens, improve information-sharing and comply with President Trump's two-for-one regulations order.
The US FDA commissioner says the agency has gone through sporadic reviews of regulations, but he would like to see a more systematic process to continuously evaluate whether regulations should be modified or withdrawn.