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 the impact of a federal judge’s decision that the recent ACIP membership turnover and vaccine schedule changes likely violated statutes, as well as the FDA’s look at new opioid disposal requirements.
Pink Sheet editors discuss the direction of the FDA and CBER after Vinay Prasad’s exit, CBER’s similarities to the Harry Potter saga, as well as the Real-Time Oncology Review pilot’s contributions to Commissioner’s National Priority Voucher approval times.
Generics Bulletin editor Dave Wallace joins Pink Sheet editors to discuss the generics and biosimilars industries’ priorities following the recent AAM Access! 2026 conference, as well as FDA Commissioner Martin Makary’s interesting take on the compassionate use program.
Pink Sheet editors discuss the generic and biosimilars industries’ 2026 priorities as well as FDA Commissioner Martin Makary’s interesting take on the compassionate use program.
As FDA streamlines regulatory requirements for biosimilars, Robert Foster said during AAM’s annual meeting that if a company brings high-quality data to the agency, ‘sometimes the student ... teaches the tenured professor something new.’
As FDA streamlines regulatory requirements for biosimilars, Robert Foster said during AAM’s annual meeting that if a company brings high-quality data to the agency, ‘sometimes the student ... teaches the tenured professor something new.’