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Paula Katz advises clients on pharmaceutical compliance and enforcement. She joined the firm after serving as Director of Guidance and Policy for the Office of Manufacturing Quality in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). While at the FDA, Ms. Katz focused on current good manufacturing practice (CGMP) enforcement and drug quality policy issues. She advised CDER and FDA leadership regarding manufacturing supply chain controls, contract manufacturing, data and application integrity, administrative law and procedure, and regulatory policy development and enforcement strategy.

  • Advice on FDA inspection responses, including several that successfully resulted in VAI classifications at those sites, interactions with regulatory authorities, and managing compliance and enforcement actions.
  • Conduct investigations into potential GMP or GCP violations.
  • Advice on regulatory issues in their commercial agreements, including ancillary agreements such as Quality Agreements and Pharmacovigilance Agreements.
  • Regularly counsel on drug and biologics recall issues.

Memberships and Affiliations

  • Parenteral Drug Association
  • Food and Drug Law Institute
  • International Society of Pharmaceutical Engineers

Previous Experience

  • U.S. Food and Drug Administration, Director, Manufacturing Quality Guidance and Policy Staff