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M. Nielsen Hobbs
Executive Editor
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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.
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.
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.
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.
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.
Keeping Track: Approvals For Mayzent, Mavenclad, Duaklir, Jatenzo And Cimzia
The latest drug development news and highlights from our US FDA Performance Tracker.