Food, Drug & Medical Device Regulatory

McDermott’s US Food and Drug Administration (FDA) practice provides comprehensive regulatory and strategic advice to pharmaceutical, biotechnology, medical device, dietary-supplement and food companies, as well as digital-health technology developers and clinical research organizations. We counsel clients on the development, manufacture, marketing and promotion, and reimbursement of drugs, biologics, devices and other products regulated by the FDA.

Our lawyers are nationally recognized as leading lawyers in FDA law by US News-Best Lawyers and LMG Life Sciences and offer industry experience, practical solutions and diverse perspectives to address complex problems facing life sciences companies. Members of our team have worked at FDA in legal and regulatory positions and held senior legal and compliance roles in pharmaceutical and biotech companies.

Our broad experience allows us to benchmark and characterize industry trends to provide thoughtful and practical risk assessments and strategic advice. Our lawyers focus on a variety of legal issues, including manufacturing and quality, advertising and promotion, clinical research, diagnostic testing and post-market compliance.

We leverage our global platform and complimentary practices to provide interdisciplinary advice to our life sciences clients on issues such as intellectual property, data privacy and security, litigation, pricing, reimbursement and health care compliance. We advise clients on the following:

• Current Good Manufacturing Practice (cGMP), Medical Device Quality System Regulation (QSR), Good Clinical Practice (GCP), internal compliance programs, internal and external audits, and standard operating procedures (SOPs)
• Marketing applications and other regulatory submissions, product labeling, advertising and promotions, and post-market surveillance
• Product regulatory status determinations, import-export compliance, and other pre- and post-market regulatory programs
• FDA inspection preparedness and responses to FDA Inspectional Observations (483s), warning letters and other regulatory communications
• FDA investigations, FDA consent decrees and other enforcement actions involving the FDA, the US Department of Justice (DOJ), state attorneys general, other federal and state agencies, the US Congress, and False Claims Act qui tam and other litigants
• Compliance program implementation, auditing and monitoring in accordance with OIG’s Seven Elements of an Effective Compliance Program and applicable PhRMA Code/ADVAMED industry standards and applicable laws and regulations
• Development and submission of citizen petitions, trade complaints and comments on FDA proposed rules and guidance
• Entry into the United States of non-US companies through clinical-study, approval, prelaunch, compliance-program and other initiatives