Overview
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, Paul was a lawyer at several large national law firms.
Results
- Represented clients before the FDA on several occasions, successfully persuading the agency to decline regulating client medical products and wellness tools, often after the clients had received regulatory inquiries from FDA*
- Advised an emerging pharmacy on drugs eligible for compounding under FDA law and performed regular labeling and advertising reviews, enabling the client to market its compounded medications compliantly and expand operations into new territories.*
- Secured priority regulatory designation for a tissue product client, enhancing FDA interactions and expediting regulatory review of the tissue product’s marketing application*
- Designed several phased regulatory strategies that position client offerings as consumer products that avoid or minimize FDA oversight to earn revenue while data is being generated to support the products’ future medical claims and/or functionalities*
- Advised several medical and consumer product manufacturers on whether product recalls or regulatory notifications were warranted based on product performance in the field. These decisions were not disputed by FDA during routine manufacturer inspections*
- Created a change of ownership plan for a portfolio of state licenses relating to the sale of a medical device company resulting in the uninterrupted sale of the acquired devices following the transaction*
- Guided a medical product company on the establishment and implementation of corrective actions that addressed FDA inspectional findings and were considered adequately responsive resulting in the closure of the inspection*
- Successfully petitioned FDA to take action against a medical product’s competitors that were marketing alleged “consumer products” with express and implied medical claims without the requisite FDA authorizations*
- Developed regulatory sections of the business overview and risk factors of an S-1 for an IPO of a prominent hybrid medical product and consumer product company IPO*
- Successfully represented a private equity firm in regulatory matters surrounding a gestational surrogacy platform purchase and bolt-on acquisitions*
- Provided streamlined regulatory diligence of several dozen publicly traded drug, biologic and medical device issuers on behalf of investment bank underwriters*
* matter handled prior to joining McDermott
Credentials
Education
University of Maryland Francis King Carey School of Law, JD, 2009
University of Maryland, BS, 2004
Admissions
California
Maryland
