Day: June 25, 2020

Stem cell clinics should file INDs immediately, patients looking for stem cell treatments should only do so for those offered under INDs, patients should ask for informed consent, not pay for the treatment, and report adverse events. Or so FDA would want to see. In an article last week in the Journal of American Medical … Read more

In a rare criticism of FDA’s requirements for clinical trials, two former commissioners of FDA, Scott Gottlieb and Mark McClellan, argue that FDA should allow practical trial designs of the kind used to evaluate dexamethasone treatment in COVID patients in the UK where data collection was “limited to most important measures of disease severity and … Read more