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M. Nielsen Hobbs

Executive Editor, US Regulatory & Policy

Washington, DC

Nielsen has been covering the pharmaceutical industry most of his life, reporting on everything from ANDAs to Zika vaccines. He strongly believes that the user fee system needs to stop using Roman numerals. His favorite stories are ones that help readers understand the personalities and policies that dictate whether their regulatory strategy succeeds or fails. A regular contributor to the Pink Sheet podcast, he also creates infographics and editorial feature images for articles. Before joining Pink Sheet he worked for Congressional Quarterly. Nielsen frequently moderates webinars and panels at industry conferences, and enjoys discussing R2-D2 almost as much as he enjoys talking about 351(k).

Latest From M. Nielsen Hobbs

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US FDA’s Post-Aduhelm Reforms Include Updated Alzheimer’s Development Guidance, Record-Keeping On Sponsor Meetings

Agency already had an action plan in hand to address concerns with the aducanumab review even before the controversial approval, but it has not been fully implemented yet. A House committee report is another nudge.

Leadership Drug Approval Standards

Generic Policy Tweaks In Omnibus Legislation Include Processes Improvements On Late-Stage Label Changes, 505(b)(2) TE Designations

FDA will be able to approve some interchangeable biosimilars more smoothly, but won’t be instructed to provide ANDA sponsors with more information on the inactive ingredients in brand drugs.

Generic Drugs Biosimilars

Requiem For Cures 2.0: An Idea Whose Time Has Come, But Will Still Have To Wait

The Upton-DeGette legislation wasn’t going to be part of the omnibus bill moving through Congress this week, but its original concepts – creating more clarity on CMS reimbursement – seem as critical as ever.

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