Heightened regulatory scrutiny, changing approval pathways, and complex product disputes have made a clear understanding of FDA processes essential in litigation. DOAR represents former professionals from the FDA who have shaped policy, led breakthrough initiatives, and navigated the intricate pathways of regulatory science, enabling them to serve as an FDA expert witness in matters involving the development, regulation, and commercialization of drugs, biologics, and medical devices.
Our network includes former agency officials and senior staff who understand the full regulatory lifecycle, ranging from clinical trials and FDA submissions through approval, post-market surveillance, manufacturing quality, and labeling. As regulatory affairs and FDA regulatory expert witnesses, they offer practical insight into how decisions are made inside the Food and Drug Administration and how those expectations apply to specific products and companies.
In matters involving product safety, clinical pharmacology, manufacturing practices, or promotional claims, our former FDA professionals provide clear, grounded testimony and analysis. Drawing on their experience as regulatory affairs specialists, they help legal teams analyze alleged regulatory failures, product safety issues, and marketing practices, and present complex FDA processes in terms that judges, juries, and regulators can readily understand.
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Areas of Expertise
We represent experts who are world-class academics, industry executives, and former government regulators who were carefully selected for their knowledge, experience, and ability to communicate effectively.
FDA Regulatory Interpretations & Practices
Expertise in FDA regulatory frameworks and internal practices, including how agency decisions are made, documented, and applied in specific matters.
Clinical & Nonclinical Data Evaluation
Experience evaluating clinical trials and nonclinical studies for scientific rigor, safety and efficacy support, and relevance to regulatory or contractual obligations.
FDA Approval Pathways & Exclusivity Issues
Knowledge of FDA approval routes, market exclusivity, and regulatory timelines, and how they affect competitive positioning and product strategy.
Risk Management & REMS Compliance
Focus on FDA risk management requirements and REMS programs, including design, implementation, and adherence to mitigation and monitoring obligations.
Post-market Surveillance & Safety Reporting
Insight into pharmacovigilance systems, adverse event reporting, and other post-market safety obligations that shape regulatory compliance and product risk.
Manufacturing Compliance (CMC & GMP)
Background in CMC requirements, GMP standards, and FDA inspections, assessing how manufacturing quality and process controls impact regulatory status and disputes.
Labeling, Promotion & Marketing Compliance
Experience assessing FDA labeling requirements, promotional communications, and advertising practices, including claims substantiation and potential misbranding issues.
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