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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).
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Latest From M. Nielsen Hobbs

US FDA Commissioner Nominee Hahn On Fast Track With 20 November Hearing

Stephen Hahn will go before the Senate health committee less than three weeks after being nominated. Pink Sheet's historical charts illustrate how a long wait and a quick hearing could mean a rapid confirmation.

FDA Appointments

Drug Review Reorganization At US FDA Coming Into Focus

Oncology, neuroscience, and infectious diseases get acting directors as the expansion and renovation of the Office of New Drugs moves into Phase II.

Drug Review Leadership

US FDA Commissioner Nominee On Fast Track With Nov. 20 Hearing

Stephen Hahn will go before the Senate health committee less than three weeks after being nominated. Pink Sheet's historical charts illustrate how a long wait and a quick hearing could mean a rapid confirmation.

Leadership FDA

Pelosi Rx Pricing Bill Offers Big Savings, Big Drop In Drug Development – CBO

Overall effect on health of US families stemming from increased use of drugs but decreased availability of new drugs is 'unclear,' the Congressional Budget Office concludes in its preliminary analysis of HR 3.

Pricing Debate Legislation

Trump's Rx Importation Plan: Sound and Fury, Signifying Something

Proposal is more of a plan to make a plan, but Pharma should realize that time is running out on its existing policy strategies.

Pricing Debate Politics

Adaptive Trial Designs Need Elaborate Firewalls To Prevent Data "Leakage," US FDA Says

Sponsors should realize that only a very few people – think 4, not 50 – will be permitted to be unblinded, CDER's Laura Lee Johnson tells the DIA annual meeting.

Clinical Trials Research and Development Strategies
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