McDermott Will & Schulte, a global law firm

James (Jamie) Ravitz is the co-head of the firm’s Life Sciences industry practice and head of the Food and Drug Administration (FDA) practice. He works alongside clients across the entire spectrum of life sciences and healthcare law, including regulatory counsel, compliance, and investigations and government enforcement. He is particularly focused on Food and Drug Administration (FDA) regulatory counseling. Jamie works in partnership with companies and investors across the complete ecosystem of FDA-regulated products — drugs, devices, health technologies, biologics, food, cosmetics and cannabis — to help them achieve their business goals.

Jamie works with manufacturers and distributors of FDA-regulated products, with deep experience on novel drugs, biologics, and cutting-edge products, from the product concept stage through to post-market and product marketing to facilitate market success and reduce enforcement risk. Jamie is a valuable addition to healthcare and life sciences transaction matters, assisting clients with FDA-related due diligence to maximize value and minimize risk and roadblocks during the transaction.

When compliance or enforcement matters arise, Jamie takes a proactive, business-focused approach to address the issues with minimal business disruption. He also works with clients on the regulatory components of internal investigations, enforcement activity, and consumer protection litigation when they arise. He has worked with clients on numerous internal investigations and responses to Office of Inspector General (OIG) and US Department of Justice (DOJ) subpoenas and has assisted in the defense and settlement of qui tam whistleblower suits alleging violations of the False Claims Act.

Jamie is a recognized thought leader in the health law and medical device spaces. He is a regular speaker at health and life sciences industry conferences and has served as an advisory board member to bio-innovation centers and trade media editorial boards.

Prior to joining McDermott Will & Schulte, Jamie served as leader of the FDA, healthcare, and consumer products compliance practice at a large international law firm.

Paul Gadiock leverages his firsthand experience at the Food and Drug Administration (FDA) to provide life sciences, healthcare and other FDA-regulated companies with practical, strategic counsel at every phase of the product life cycle. Paul supports medical device, digital therapeutic, and biopharma companies, drug compounders, software as a medical device (SaMD) and clinical decision support (CDS) developers, and their investors on their FDA regulatory and due diligence needs, delivering premarket and postmarket regulatory guidance to maximize business outcomes.

From providing strategic regulatory direction at the product concept stage through post-marketing issues such as product marketing, labeling, advertising, and recalls and crisis matters, Paul has substantial experience helping his clients bring novel technologies and innovative products to market and maintain competitive advantages. His deep experience allows him to provide practical, business-minded due diligence support to buyers, sellers and investors in achieving their transaction goals.

As a member of the senior leadership team at the FDA’s Center for Devices and Radiological Health, Paul advised agency officials on issues related to the regulatory scope of the FDA’s policies, programs, regulations, and legislation to the medical device industry. He also collaborated with the Office of Inspector General (OIG) and Government Accountability Office (GAO) on analyses, investigations and oversight of major national programs.

In addition to his government experience, Paul provides a commercially minded approach rooted in real-world experience as a business development executive at a national diagnostic biotechnology company. In that role, he worked with an international team on market entry and regulatory compliance issues to effectively launch and promote products in new market. Prior to joining McDermott Will & Schulte, Paul was a lawyer at several large national law firms.