Fda Regulatory Expert Witnesses

Pharmaceutical Regulation, Medical Devices - FDA, FDA expert FDA Compliance, FDA Regulations, FDA MAUDE , FDA Drug Safety, FDA Warnings, FDA Drug Warnings FDA Medical Device expert, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability

Dr. Sharlin’s experience: My key skill is identifying and developing facts supporting a legal strategy. (1) Drug reviewer at FDA. (2) Expert witness experience: Cases-37, Expert reports-16, Depositions-8, Testimony-1, Successful Daubert challenges-0. (3) Professional experience: Regulatory consultant (25 years), expert witness (10 years). (4) My cases have involved drug and medical device death and injury, patents, mergers, trade secrets, business interruption insurance, product labeling. (5) My skills: biological scientist, statistician, software developer, data integrity specialist, technical writer, educator, and FDA regulatory expert. (6) Talented technical writer, my writing experience includes:  Expert reports, scientific publications, audit reports for FDA compliance, standard operating procedures, FDA submissions, responses to questions from FDA. (7) I write custom software for data mining of safety information from FDA’s adverse event databases:  I extract f...

Medical Devices, Pharmaceutical Regulation - FDA, FDA expert, FDA regulatory, FDA medical device, FDA medical product expert, FDA medical product regulation, FDA medical device regulation, FDA compliance, FDA medical product compliance, FDA medical device quality, FDA warning letter, FDA enforcement, FDA consent decree, FDA quality system

Steve Silverman is an FDA regulatory expert with more than a decade in FDA leadership roles, including as the Director of the Office of Compliance in the medical-device center. Steve focuses on areas including post-market regulation, regulatory compliance and enforcement, medical device quality, and building effective business-regulator relationships. Steve is the President of The Silverman Group, a consultancy that serves medical product companies on regulatory, strategy, and policy issues. Before this, Steve worked as Vice President, Technology and Regulatory Affairs, with AdvaMed, the leading medical-device trade association. Steve focused there on device quality and compliance, pre-market approval, advertising and promotion, and combination products. Steve brings to these roles global consulting experience with McKinsey & Co. and a range of FDA leadership positions. At FDA, Steve directed the Center for Devices Office of Compliance, where he led device-quality initiatives, enga...