FDA commissioner Robert Califf calls on health insurers to play a role in seeing that confirmatory trials are completed for drugs approved through the...
PhRMA suggests changes to an FDA revised draft guidance on the content and format of the Dosing and Administration section of drug labeling.
FDA revises the fact sheets on Janssens Covid-19 vaccine to include a warning about reported adverse events that suggest increased risks of myocarditi...
FDA clears a TytoCare 510(k) for its Tyto Insights for Wheeze Detection, an algorithm for use on the companys existing artificial intelligence-powered...
FDA publishes a draft guidance on using electronic systems, records, and signatures in clinical investigations of some regulated products.
FDA modifies a partial clinical hold against Stoke Therapeutics to allow the administration of a higher single dose of STK-001 (70 mg) in its ongoing ...
Sens. Paul and Hassan reintroduce their bill to require FDA to more clearly identify differences between generic drugs that have been submitted for ap...
The Department of Justice says former drug sales representative Vincent Tornari pled guilty to one count of healthcare fraud and wire fraud involving ...
