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
Pink Sheet editors discuss new information on the Commissioner’s National Priority Voucher Program, including the role of the center directors and the Commissioner’s National Priority Voucher Review Council in application reviews.
Pink Sheet editors discuss the average speed of FDA novel drug application reviews in 2025 and consider whether staffing departures and general upheaval throughout the year will impact times in 2026.
Pink Sheet editors discuss Richard Pazdur’s concerns about the Commissioner’s National Priority Voucher program and the idea that the FDA could release action packages for unapproved products in addition to complete response letters.
Pink Sheet editors and special guest Michael McCaughan discuss the legacy of long-time Oncology Center of Excellence Director Richard Pazdur, who retired from the FDA in December.
Pink Sheet reporter and editors discuss the likely impacts of Center for Drug Evaluation and Research Director Richard Pazdur’s retirement from the FDA and Tracy Beth Høeg becoming the center’s acting director.
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.