PDUFA Stars Aligning As House Draft Gives FDA Direct Authority Over Importers
This article was originally published in The Pink Sheet Daily
Latest version of potential House user fee bill eliminates revisions to FDA’s mission statement and includes provisions for approving breakthrough technologies and destroying unsafe drug imports at the border.
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As the agency and stakeholders gear up for public hearing, Sandoz argues that since Europe has not addressed interchangeability, FDA could step to the forefront by focusing on it as part of implementing the U.S. biosimilar pathway.
Opening statements in the House Energy and Commerce’s Health Subcommittee’s markup took longer than the legislative activity, which consisted of a technical amendment and two colloquys. Next stop on the user fee express: Upton-town on Thursday.
Senate health committee defers action on several potentially contentious issues, with members hoping to resolve differences over FDA’s authorities on imports, shortages, foreign data and track-and-trace before the bill goes to the floor, possibly in May. Meanwhile, the House postpones its mark-up in an effort to craft a more bipartisan bill, and now will try to push the user fee package to the floor during an upcoming four-day marathon session.