Device trial female populations should reflect disease prevalence -- FDA panel chair.
This article was originally published in The Gray Sheet
Executive SummaryMEDICAL DEVICE STUDY FEMALE POPULATIONS BASED ON DISEASE PREVALENCE is recommended by FDA Circulatory Systems Devices Panel Chair Julie Swain, MD, Debakey Heart Institute, Kenosha, Wisconsin. Speaking at a recent FDA-sponsored workshop on gender issues in clinical studies, Swain stated that in reviewing device study protocols for approval applications, FDA needs to "make sure that women are included not just in the general population receiving that device or having intervention for that disease but in particular in an appropriate number."
You may also be interested in...
ConMed Corp. is company of two halves ̶ general surgery and orthopedics – and is readying itself for a renewed assault on these two markets on the back of a technology pipeline, targeted acquisitions and a new growth-winning culture, says CFO Todd Garner.
Drug pricing and access issues expose the pharmaceutical sector especially acutely to calls for companies to meet ethical and social goals, alongside commercial ones. Digital is up-ending pharma’s processes, its workplaces and its consumers. R&D productivity is spluttering. Amid this turmoil, CEOs highlight company culture – the way an organization behaves – as a crucial ingredient for success. But what is a “right” culture? Organizational culture is neither static nor singular. It is continuously influenced by acquisitions, markets, new technologies and new generations. And pharma’s history suggests that culture change cannot happen without sufficient people change.