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, Hobbs also creates infographics and editorial feature images for articles. Before joining the Pink Sheet he worked for Congressional Quarterly. Hobbs 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: Finally, A US FDA User Fee Deal, ‘Pandemic Is Over’ Take-Aways, Tpoxx Development Issues
Pink Sheet reporters and editor discuss the impact of the long wait for a user fee deal to be negotiated, how the FDA will interpret President Biden’s statement that the COVID-19 pandemic is over, and concerns with the clinical development of the monkeypox treatment Tpoxx.
Pink Sheet reporters and editor discuss the emergency use authorization for the updated COVID-19 vaccines, the new FDA Overdose Prevention Framework, and key decisions and deadlines upcoming in September.
FDA Commissioner says the new shots will skip advisory committee review after June meeting on reformulation. ‘As we know from prior experience, strain changes can be made without affecting safety.’
Pink Sheet reporters and editor discuss the new monkeypox vaccine EUA, the potential impact of drug pricing legislation, and how things may have been different if the FDA already had a desired technology upgrade.
Discussions through the WHO are aimed at educating low- and middle-income countries, while efforts with ‘the larger regulators’ aim to reduce the development burden for products targeting ultra-rare diseases, CBER director Peter Marks tell DIA.
Acknowledging the toll that vaccine opponents have taken on FDA operations, the CBER director emphasizes the need to create stand-by manufacturing capacity, conduct faster studies in special populations, and better understand the mRNA platform.