Wiley Expands Food & Drug Practice with Addition of Partner Rebecca Dandeker

October 14, 2025

Washington, DC – Wiley is pleased to announce that Rebecca L. Dandeker has joined the firm as a partner in the Food & Drug Practice. With three decades of experience counseling clients on products regulated by the U.S. Food and Drug Administration (FDA), Dandeker advises on prescription (Rx) pharmaceuticals, biologics, and consumer health products including dietary supplements, cosmetics, and over-the-counter (OTC) medications.

Throughout her career, Dandeker has advised companies in the pharmaceutical and personal care industries on the full spectrum of FDA laws and regulations. She has extensive experience guiding clients through product development and approval, labeling and advertising compliance, post-market obligations, and government enforcement defense. She also responds to inquiries from the U.S. Department of Health and Human Services (HHS), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), and similar state agencies regulating ingredients that impact public health.

“Companies today face a complex regulatory environment that directly influences how they innovate and compete,” said Peter D. Shields, Managing Partner of Wiley. “Rebecca’s experience advising pharmaceutical and consumer health companies further strengthens our ability to help clients navigate federal regulation with the practical insight needed to align compliance, market strategy, and long-term growth.”

Dandeker also has extensive experience advising on the regulatory aspects of life sciences transactions, conducting due diligence and assessing disclosure and risk considerations in corporate and M&A deals. She regularly assists companies in managing FDA inspections, warning letters, and remediation efforts, helping to develop corrective action plans and long-term compliance strategies.

“Rebecca’s understanding of the FDA framework and its practical application is exceptional,” said Ann M. Begley, chair of Wiley’s Food & Drug Practice. “She combines technical depth with the clarity and collaboration that clients value, translating complex regulatory requirements into practical strategies that help them compete and grow in highly regulated markets.”

At Wiley, Dandeker will continue advising companies on FDA matters across the product lifecycle – from pre-approval strategy to manufacturing standards and post-launch requirements. She will also counsel clients on policy and legislative issues that affect product development and commercialization, including those with overlapping FDA and intellectual property considerations such as Hatch-Waxman rules, market exclusivity protections, and the biologics “patent dance.”

“I’m excited to join Wiley, a firm that brings together exceptional regulatory knowledge and government experience under one roof,” said Dandeker. “Wiley’s commitment to cross-practice collaboration offers an ideal opportunity to expand my practice and work with colleagues who understand how government agencies operate and how regulatory decisions shape the marketplace. That combination of insight and perspective is critical for clients seeking to anticipate change, manage compliance obligations, and bring innovative products to market.”

Wiley’s Food & Drug Practice operates at the intersection of law, policy, business, technology, and scientific innovation. Dandeker’s arrival follows the recent addition of former U.S. Department of Agriculture (USDA) Acting General Counsel Mary Beth Schultz, reflecting Wiley’s continued investment in the strategic growth of its regulatory and life sciences capabilities. The team counsels clients across the product lifecycle, from development and approval to marketing, labeling, and post-market compliance. With deep experience across FDA, USDA, DEA, and related agencies, the practice helps clients navigate regulatory frameworks, respond to enforcement actions, and adapt to evolving policy priorities impacting industries including food, dietary supplements, cosmetics, pharmaceuticals, medical devices, and agricultural products.