Former FDA

In an era of heightened regulatory scrutiny, evolving drug approval pathways, and increasingly complex disputes, the role of former FDA experts in litigation strategies has never been more critical. WIT represents the most qualified experts in this sector for litigation involving the science, regulation, and commercialization of drugs, biologics, and medical devices. Our team of distinguished former FDA professionals has shaped policy, led breakthrough initiatives, and navigated the intricate pathways of regulatory science.

As the pharmaceutical and medical device industries face growing challenges around safety, compliance, and commercialization, litigators need trusted insight into the inner workings of the U.S. Food and Drug Administration. Our experts include former agency officials, industry executives, and leading academics who understand the full regulatory lifecycle—from clinical development and FDA approval to post-market compliance, manufacturing standards, and labeling requirements. With firsthand experience shaping and enforcing FDA policy, they were carefully selected for their knowledge, experience, and ability to communicate effectively in cases involving product safety, regulatory failure, and marketing practices.

Former FDA Expert Team

WIT represents leading regulatory experts formerly with the FDA who bring years of experience at the agency, having reached GS-14, GS-15, or Senior Executive Service (SES) levels. These experts possess deep specialization in specific regulatory domains, have played key roles in policy development and implementation, maintain distinguished publication records in regulatory science, and have a history of influential participation in advisory committees.

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Our Experts

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 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.