M. Nielsen Hobbs
Executive Editor
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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.
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.
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.
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.
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.
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.