David Horowitz brings 25 years of combined experience at the FDA and US Department of Health and Human Services (HHS) to help clients anticipate and navigate complex regulatory compliance challenges. David’s practice focuses on pharmaceutical compliance issues, including Current Good Manufacturing Practice (CGMP), inspections, recalls, post-market reporting, import/export, drug supply chain security, pharmacy issues, and OTC drug issues. During his time at HHS and FDA, he developed a deep understanding of the institutions, organizational structures, procedures, and cultures through which regulatory policy and compliance decisions are considered, developed, and implemented across all branches of government. The combination of his deep technical knowledge and years of experience allows David to provide strategic and tactical advice to proactively avoid regulatory problems, as well as respond effectively to unanticipated challenges.