M. Nielsen Hobbs
Executive Editor, US Regulatory & Policy
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
Insulin Prices, Cancer Treatment Innovation Pushed In State Of The Union As Biden Faces Divided Congress
Expanded federal research efforts around cancer treatment was one of a handful of bipartisan goals that President Biden highlighted in his State of the Union address.
Pink Sheet Podcast: US FDA Loses Gene Therapy Expert, Humira Biosimilars Launch, FDA Allows In-Person Meetings
Pink Sheet reporters and editors consider the impact of FDA Office of Tissues and Advanced Therapies Director Wilson Bryan’s retirement, the launch of Humira biosimilars and its effect on the biologic market, as well as the FDA moving to hybrid meetings with sponsors.
Califf Laments Shift To Ex-US Clinical Trials – As Well As Pace Of Reforms At Home
US FDA commissioner tells J.P. Morgan conference that the agency, industry, and the entire healthcare system need to change ‘at the same time’ in order for clinical trials to improve.
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.
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.
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.