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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

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

Medicare CAR-T Coverage Decision Appears Hung Up In Political Review, Former CMS Official Says

Proliferation of expensive accelerated approval products requires "a revision to the existing evidence and policy approach for payers," Sean Tunis tells the DIA annual meeting.

Medicare Cancer

Real-World Evidence: Replication of Controlled Trials Expected To Fail Sometimes, US FDA Says

Agency study deliberately not weighting RWE populations the same as RCTs it aims to duplicate. "We learn the most when we don't replicate," Harvard Medical School's Jessica Franklin tells the DIA annual meeting.

Post Market Regulation & Studies Clinical Trials

Data Aggregation Standards Should Be Based On HIPAA, CRO Association Chief Argues

Efforts by US states such as California to create their own deidentification standards could be very disruptive, ACRO's Doug Peddicord tells DIA annual meeting.

Legal Issues Research and Development Strategies

Keeping Track: Approvals For Mayzent, Mavenclad, Duaklir, Jatenzo And Cimzia

The latest drug development news and highlights from our US FDA Performance Tracker.

Drug Review Regulation
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