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 Nielsen Hobbs
Issues that had been concerns in Trump’s first term are realities now, but industry has also seen some successes. Trump’s personalistic style of governance means that larger firms may be at an advantage because of their greater flexibility to cut deals on individual products.
Pink Sheet reporter and editors explain Tidmarsh’s abrupt resignation as the FDA’s chief drug regulator and the potential impact on the already reeling agency.
Pink Sheet editors discuss FDA announcements that clinical efficacy studies would no longer be required for biosimilar development, as well as the additional information from the agency on the intent of its “Simple Reform” of the inspection staff.
Pink Sheet reporter and editors discuss the FDA’s plans to undo a previous reorganization and make facility and other inspectors generalists again, as well as industry efforts to adapt to the new direct-to-consumer advertising landscape.
Pink Sheet reporter and editors discuss the FDA’s role in the Astra Zeneca Most Favored Nation drug pricing deal and the Justice Department interpreting the off-label promotion laws differently than the FDA.
Pink Sheet reporter and editors discuss the FDA’s decision to remove the “adequate provision” loophole in its advertising regulations and other pharma industry issues that emerged from the Make America Health Again Commission report.