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