Paula Katz is a regulatory attorney with nearly 20 years of experience in pharmaceutical and medical products compliance and enforcement matters. Prior to joining the firm, Paula was the Director of Guidance and Policy in FDA's Center for Drug Evaluation and Research, Office of Manufacturing Quality. At FDA, Paula was responsible for development of current good manufacturing practice (CGMP) and drug quality policy and served as a clearing official on drug quality compliance actions. Paula brings her years of FDA experience to bear in providing clients with practical advice on a wide range of regulatory compliance and enforcement issues, including managing and responding to regulatory inspections, quality and safety reporting, regulatory outreach, product recalls, and investigations. She also routinely advises on regulatory aspects of commercial agreements and life sciences transactions and provides critical subject matter expertise to support commercial and government litigation and investigations.