OTC Monograph User Fees Up To $34M Floated In Senate Discussion Draft
This article was originally published in The Rose Sheet
Executive Summary
Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.
You may also be interested in...
Trump's Budget Surprise: FDA Gets 13% Increase
President Trump's FY 2019 budget request includes $473m in new non-user fee revenue for the US agency, a reversal of the previous year's request.
OTC Monograph Reform Momentum Carries Potential Exclusivity Snag
Support was unanimous during House Health Subcommittee markup for draft legislation on streamlining FDA's monograph system by eliminating public rulemakings from the process and allowing the agency to make decisions with administrative orders. Two-year exclusivity for some products didn't go over so well.
Rep. Pallone Galvanized By FDA's 'Troubling Overview' Of Cosmetic Imports
FDA physically inspected less than 1% of the 2.9m cosmetic imports that reached the US in fiscal 2016, according to a letter from the agency released by Congressman Frank Pallone. The ranking member of the House Energy and Commerce Committee says he's aiming for a hearing in September on his bipartisan proposal to increase FDA's authority over the cosmetics sector.