M. Nielsen Hobbs
Interim Editor-in-Chief, Pink Sheet
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
Pink Sheet Podcast: What’s In And Out Of US FDA’s Diversity Action Plan Guidance, AI Guidance Also Coming
Pink Sheet reporter and editors discuss what the FDA included in its long-awaited guidance on clinical trial diversity action plans, along with what was left out, as well as an upcoming guidance on the use of artificial intelligence in regulatory decision-making.
US FDA Guidance On Artificial Intelligence For Regulatory Decision-Making Expected This Year
Draft guidance will offer a risk-based framework for accessing the credibility of AI and help ensure that AI models used to answer regulatory questions are sufficiently credible for a particular ‘context of use,’ CDER’s Tala Fakhouri says.
Clinical Trial Diversity Action Plan Waivers Will Be ‘Very Rare,’ US FDA Official Says
With the much-anticipated guidance still pending, OCE’s Tamy Kim reminds industry of the requirements and timing around avoiding the soon-to-be requirements on study enrollments.
Pink Sheet Podcast: Clinical Trial Reg Issues, NIH Drug ‘Access Plans’, Good Ole Days Of Woodcock
Pink Sheet editors discuss the US FDA’s potential regulatory changes to promote novel trial designs, an NIH proposal to better ensure access to a commercialized product, and lawmakers longing for Janet Woodcock's days running the Center for Drug Evaluation and Research.
Pink Sheet Podcast: BIOSECURE Act Advances, Trial Diversity Sticks, Platform Principles Without Designation
Pink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee, whether industry would improve clinical trial diversity with tougher enforcement of the regulation, as some have suggested, and the FDA’s use of platform technology ideas for gene therapies not participating in the program.
As Biosecure Bill Moves Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs
Pink Sheet infographic details the timeframes and potential extensions under the House version of the bill, which just cleared committee.