Former FDA Expert Team
As a former FDA leader, your expertise gives you a unique opportunity to use your specialized knowledge to advise lawyers at top law firms on today’s complex regulatory landscape.
Our team of distinguished former FDA professionals has shaped policy, led breakthrough initiatives, and navigated the intricate pathways of regulatory science. Our FDA experts provide expert testimony that includes:
- Explaining complex regulatory frameworks
- Interpreting FDA communications
- Providing context for agency decisions
- Evaluating whether parties acted according to regulatory expectations and requirements
The Caliber of Our Experts
WIT represents leading regulatory experts formerly with the FDA who have:
- Years of experience working at the FDA, reaching GS-14, GS-15, or Senior Executive Service (SES) levels
- Deep specialization in specific regulatory domains
- Experience in policy development and implementation
- Distinguished publication records in regulatory science
- A history of influential advisory committee participation
Transform Regulatory Complexity into Clarity
Join our distinguished team of former senior FDA officials and industry experts, contributing your knowledge to shape outcomes in high-profile litigation.
Our former FDA experts provide powerful testimony and strategic guidance in pharmaceutical, biologics, and medical device litigation, including patent disputes, antitrust matters, contract litigation, and arbitration. They bring deep FDA regulatory experience and specialized scientific expertise in pharmacology, clinical sciences, pharmaceutical formulation, and advanced medical technologies.
Our experts provide targeted expertise in:
- FDA Regulatory Interpretations & Practices: Authoritative explanation of FDA regulatory interpretations and internal practices critical to litigation.
- Clinical & Nonclinical Data Evaluation: Expert assessment of the scientific rigor of clinical trials and nonclinical studies relevant to product safety, effectiveness, and contractual obligations.
- FDA Approval Pathways & Exclusivity Issues: Strategic insights into FDA approval processes, market exclusivity, and regulatory timelines impacting competitive dynamics.
- Risk Management & REMS Compliance: Thorough analysis of compliance with FDA-mandated risk mitigation strategies relevant to regulatory adherence or misrepresentation claims.
- Post-market Surveillance & Safety Reporting: Expert evaluation of pharmacovigilance practices, adverse event reporting compliance, and post-market regulatory requirements.
- Manufacturing Compliance (CMC & GMP): Deep expertise in FDA inspections, quality standards, manufacturing processes, and compliance issues affecting disputes and regulatory enforcement.