FDA Regulatory

DLA Piper’s forward-looking counsel advises on all areas of FDA regulation, including pharmaceuticals, biological products, consumer products, medical devices, clinical laboratories, combination products, food and beverages, dietary supplements, cosmetics, tobacco, and cannabis. We support research and development (R&D), product development, and regulatory filings, offering comprehensive regulatory services across the entire product life cycle.

Our team helps global companies assess and operationalize post-market requirements, including product launch strategies, labeling reviews, advertising and promotion, current Good Manufacturing Practice (cGMP) and quality management, import-export matters, and adverse event reporting.

Further, we advise on developing and executing proactive engagements with key FDA stakeholders, including initiation and preparation for product-related regulatory meetings, citizen petitions, competitor trade complaints, and comments on FDA proposed rules and guidance.

The FDA Regulatory group:

• Supports legal, compliance, regulatory, and quality personnel with the development and implementation of FDA compliance programs, policies, and procedures


• Advises on industry standards, including related to Good Clinical Practice (GCP), advertising and promotion, vendor and supplier qualification, recall strategies, and inspection readiness


• Provides strategic insights and advocacy in response to FDA investigations, warning letters, Bioresearch Monitoring (BIMO) and establishment inspections, clinical investigator disqualification proceedings, FDA Form 483 responses, and consent decree negotiation and monitoring, among others

Our team includes former FDA regulators, physicians, and scientists with decades of experience. We work closely with DLA Piper’s litigation and transactional lawyers on FDA regulatory litigation matters, deal diligence, and public disclosure – and, when cross-border guidance is needed, we leverage the firm’s global network to deliver locally informed solutions.

Drug and biologics

• Participated in a major pharmaceutical company’s promotional review committee as regulatory counsel, with responsibility for prescription anti-infective, cardiovascular, pain, and women's health drug products
• Served as regulatory counsel for a research-based pharmaceutical company in a US Supreme Court case that broadened the scope of the FDA research exemption to patent infringement under the Hatch-Waxman Amendments
• Counseled a major global pharmaceutical company on the rollout of three global, multi-site clinical trial programs across 15 jurisdictions, overseeing implementation and coordinating with local DLA Piper attorneys to negotiate and advise on local law issues. Developed clinical trial agreement templates, fallback positions, and Frequently Asked Questions documents aimed at increasing the speed of execution of clinical trial agreements across sites and standardizing the executed terms of the agreements
• Represented a global pharmaceutical company in litigation against FDA and the patent office under the Administrative Procedure Act seeking reversal of patent term extension denial based on arbitrary, capricious, and unlawful application of drug approval requirements
• Counsels a global pharmaceutical company in Formal Dispute Resolution with FDA after issuance of a Complete Response Letter based on FDA’s refusal to apply regulatory flexibility for a severe genetic condition with no approved treatment

Medical device and digital health

• Assessed a global medical device manufacturer’s consent decree and compliance commitments, advised and developed a strategy for proactive engagement with FDA regarding consent decree commitments and operations, and advised senior leadership on a Quality Assurance/Regulatory Affairs remediation strategy and global reorganization
• Advised a global medical device manufacturer on an FDA recall involving a diagnostic imaging device, including clinical risk assessments, a health hazard evaluation (HHE), a Corrective and Preventive Action (CAPA), and related quality management issues
• Advised a global manufacturer on its response to an FDA Warning Letter and associated compliance plans arising from advertising and promotion activities, including direct-to-consumer influencer marketing activities
• Assisted a technology company in obtaining an FDA breakthrough device designation for its machine-learning tool aimed at early detection of a neurodegenerative disease and disease progression tracking

Food and beverage

• Advised companies on all aspects of product labeling, including general FDA label compliance and assessment of risk regarding statements of identity, nutrient content claims, structure/function claims, product imagery, greenwashing claims, marketing and advertising, and ingredient analyses
• Represented global companies on Food Safety Modernization Act (FSMA) compliance, including related to the Food Traceability Rule, the Foreign Supplier Verification Program (FSVP), supplier verification provisions, Preventive Controls rules, and the Sanitary Transportation rule
• Advised food manufacturers and retailers on risk assessments for heavy metal contamination and other ingredients, developing testing protocols, assisting in preparation for FDA interactions, and determining whether products must be recalled
• Assisted food and beverage companies on compliance and enforcement matters, including in responses to FDA Form 483 and warning letters, investigations, and requests for recalls and market withdrawals
• Provided strategic advice on proactive and reactive measures in response to the Making America Healthy Again (MAHA) initiative, including ingredient assessments, potential product reformulations, and policy development