Examining CDRH, Device Innovation & Agency Communication

Wayne chats with Sandra Cohen Kalter, member of the Strategic Advisory Group for iTolerance and a retired legal regulatory attorney from industry, and Steve Silverman, President of the consultancy The Silverman Group. You'll hear their thoughts on how CDRH has been affected over the past year, whether the center has the resources and cross-agency collaboration it needs to fulfill its regulatory mandate, FDA's capacity to support innovation amid review pressure and staffing cuts, how companies can find reliable up-to-date regulatory information that's not available through FDA communications avenues, FDA's ability to monitor safety and performance throughout a device's life cycle, and much more. In our headlines segment, Wayne delves into these major developments:  Pharma: From STAT, biotech leaders say FDA uncertainty threatens drug development Devices: FDA alerts healthcare providers, patients, and caregivers to complications with radiofrequency microneedling devices Food: FDA remains busy with food recalls, this time for cinnamon and eggs Cosmetics: Personal Care Insights spotlights growing wave in cosmetics: human-derived ingredients In our Resource Links segment, we list key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at [email protected].  Music by Dvir Silver from Pixabay.