IND Safety Reporting: Stakeholders Tussle Over Which Adverse Events To Report, Proper Oversight Body
US FDA officials, drug sponsors discussing creation of library of adverse event rates.
You may also be interested in...
Sponsors should create safety assessment committees, draft guidance recommends.
US FDA's Pediatric Experts, Not Review Division, Should Have Final Say On Pediatric Trials, Former Official Says
Former Associate Commissioner Janice Soreth says views of pediatric experts should take precedence over those of division directors regarding pediatric trials.