On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. The draft guidance provides valuable information about what steps the FDA will expect sponsors to take to promote adequate representation across demographic characteristics in study populations.
FDA Pushes to Diversify Clinical Studies, Releases Draft Industry Guidance
By James Ravitz, Jennifer S. Geetter, Jiayan Chen, Paul Gadiock, Jeff Weinstein, Marissa Hill Daley, Nathan Gray and Karis Jackson on August 20, 2024
Posted In Employee Benefits, Health and Welfare Plans
James RavitzJames (Jamie) Ravitz is the co-head of the Firm’s Life Sciences industry practice and head of McDermott’s 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. Read James R. Ravitz's full bio.
Jennifer S. GeetterJennifer S. Geetter advises global life sciences, health care and informatics clients on legal issues attendant to biomedical innovation, research compliance, financial relationship management, digital health practices, and global privacy and data security laws. Jennifer represents a broad range of clients. Read Jennifer Geetter's full bio.
Jiayan ChenJiayan Chen is deeply experienced in the regulatory, transactional and strategic issues that arise when leveraging health information, biospecimens and technology to drive healthcare innovation and quality. She guides stakeholders on privacy compliance and research compliance and in the context of strategic initiatives and collaborations as they seek to harness the power of data, machine learning, DNA sequencing and technologies to develop and deploy new products and solutions and address challenges in healthcare delivery and payment. Read Jiayan Chen's full bio.
Paul GadiockPaul 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, 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. Read Paul S. Gadiock's full bio.
Jeff WeinsteinJeff Weinstein helps life sciences and healthcare clients navigate complex regulatory landscapes, achieve best practice compliance, manage investigations and respond to government enforcement. His preventive law mindset enables him to help clients steer clear of legal minefields and find the enterprise-transforming opportunities that the dynamic and ever-changing operating environment can offer legally astute managers. Read Jeff Weinstein's full bio.
Marissa Hill DaleyMarissa Hill Daley focuses her practice on healthcare and US Food & Drug Administration (FDA) matters, including advising clients on regulatory compliance, government and internal investigations, and FDA marketing requirements. Marissa also defends clients against whistleblower qui tam suits that involve the False Claims Act and the Anti-Kickback Statute. Read Marissa Hill Daley's full bio.
Nathan GrayNathan Gray is a member of the Healthcare Practice Group. While earning his law degree, Nathan served as a summer associate at McDermott. He was a legal fellow at Compassion and Choices in Portland, Oregon, and served as internal vice president of the Health Law Society at Duke University School of Law. Read Nathan Gray's full bio.
Karis JacksonKaris Jackson advises healthcare clients on diverse transactional and regulatory issues related to managed care, healthcare policy, US Centers for Medicare & Medicaid Services due process, and Food & Drug Administration and Federal Trade Commission guidance. Her clients include private equity and practice management companies, public and private companies, and healthcare organizations. Read Karis Jackson's full bio.
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