M. Nielsen Hobbs
Latest From M. Nielsen Hobbs
Pink Sheet Podcast: FDA User Fee Bill Mark-Up, Postmarket Quality Requirements, Fewer Adcom Meetings
Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.
The must-pass bill has many FDA policy ornaments hanging from it, but the version released by Democratic and Republican committee leadership has notable absences as well, including Cures 2.0.
Pink Sheet reporter and editor discuss next steps in the development of COVID-19 vaccines for young children, complaints about CMS’s coverage decision for Aduhelm, and the congressional investigation of McKinsey’s FDA conflicts of interest.
With the mask mandate now lifted for air travel and the grimmer milestone of one million Americans dead from COVID approaching, the Pink Sheet looks back at the generic trade association’s annual meeting to see what business gatherings may look like going forward.
CMS took pains in its final national coverage determination to try to mend fences with FDA; how the NCD will play with Medicare recipients remains an open question, especially since the Alzheimer’s-induced premium hikes remain in effect.
Pink Sheet reporter and editors discuss a grassroots campaign against coverage of a controversial Alzheimer’s treatment, the potential for drug pricing reform, and the pandemic effects on FDA hiring and retention.