Examining CDRH, Device Innovation & Agency Communication

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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.

Headlines

Pharma: From STAT, biotech leaders say FDA uncertainty threatens drug development

Pharma: FDA designates nine products for National Priority Voucher to expedite reviews of selected programs that meet certain national priorities

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

Resource Links

Pharma: Republican Senators sign letter sent to HHS and FDA urging FDA to suspend approval of new generic version of abortion pill mifepristone

Devices: FDA Digital Health Advisory Committee meeting November 6 for a virtual session on AI-powered digital mental health tools

Food: Environmental Working Group interactive map for tracking progress of U.S. state-level food chemical-related bills

Cosmetics: From Cosmetics Design USA, EU crackdown on intentionally added microplastics pushing beauty brands to overhaul formulas

About Our Guests

Sandra Cohen Kalter

Sandra Cohen Kalter, part of the Strategic Advisory Group at iTOLERANCE, Inc., and former Chief Regulatory Counsel/Vice President at Medtronic, is an influential and mission-driven legal and regulatory executive with extensive expertise in FDA law and regulatory leadership for one of the world’s leading medical device companies.

Sandy spent nearly 20 years overseeing legal strategy for global regulatory, quality, clinical, promotion and advertising, and medical safety for Medtronic, a global medical device leader with $34 billion in revenue and 90,000 employees. Prior to Medtronic, she served at two global Washington DC law firms representing medical device and pharmaceutical companies.  She held leadership positions at AdvaMed, the Food and Drug Law Institute, and Breakthrough T1D (formerly JDRF) and has authored/presented in numerous industry forums.

She was recognized with the Food and Drug Law Institute’s Service to FDLI Award in 2023, the Juvenile Diabetes Research Foundation Rappaport Lifetime Achievement Award in 2019, and Medtronic’s Wallin Leadership Award in June 2010.  

Steve Silverman

Steve Silverman is the President of The Silverman Group, a consultancy that serves medical product companies on regulatory issues. Before this, Steve was a Vice President with AdvaMed, the device trade association and he was a Senior Expert with the consulting firm McKinsey & Co.

Steve’s experience includes senior FDA roles, where he directed the device center Office of Compliance and he was the Assistant Director of the drug center’s compliance office.