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M. Nielsen Hobbs

Executive Editor

Washington DC
M. Nielsen Hobbs has more than 20 years of experience covering the pharmaceutical industry, and writes frequently about the intersection of business, regulation, science and politics. Before joining the “The Pink Sheet” he worked for Congressional Quarterly. Hobbs enjoys discussing BB-8 almost as much as he enjoys talking about 351(k).

Latest From M. Nielsen Hobbs

Pink Sheet Podcast: Dsuvia Warning Letter, Refuse-To-File Impact, CDER’s COVID Workload

Pink Sheet reporters and editor discuss the issues surrounding an FDA warning letter on Dsuvia promotion, an expected jump in CDER coronavirus-related workload, and a study of refuse-to-file actions.

Coronavirus COVID-19 Review Pathway

Pink Sheet Podcast: COVID-19 variants and vaccine trial dropouts, Aducanumab, User Fee Goal Changes

Pink Sheet reporters and editor discuss the latest coronavirus vaccine news, CMS’ effect on the future of aducanumab, as well as new assessment goals for PDUFA VII.

FDA User Fees

Pink Sheet Podcast: COVID-19 Vaccine Dose-Sparing, New Viral Variants, CMS and FDA Leader Updates

Pink Sheet reporters and editor discuss Biden’s look at coronavirus dose-sparing strategies, FDA plans for vaccine adjustments in lieu of viral variants, new CMS administrator candidates and groups lobbying for the new FDA commissioner.

Coronavirus COVID-19 Vaccines

Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

FDA Leadership

Operation Warp Speed’s Difficult Holiday Season

The US missed even its revised year-end target for COVID vaccines, but the news isn’t all bad; there’s steady progress on clinical research even as federal officials seem out of ideas for how to speed actual vaccinations.

Coronavirus COVID-19 Vaccines

Pfizer Vaccine Shortfalls: Warp Speed’s Perna Takes Responsibility, Cites Lot Release Confusion

States had received less than they expected, and Operation Warp Speed and Pfizer had taken swipes at each other, but that all seems smoothed over now – even though it’s still not exactly clear how much of Pfizer’s COVID vaccine will be available to the US by the end of year.

Manufacturing Vaccines
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