Practices  |  Food, Drug, and Medical Device Law

FDA Regulatory Compliance

Overview

We advise companies on compliance with Food and Drug Administration (FDA) regulations, guidance, policies, and procedures regarding medical devices, drugs, food, cosmetics, and dietary supplements. Our compliance counseling experience spans a broad range of contexts including:

  • Development of effective compliance programs for pharmaceutical and medical device manufacturers, including standard operating procedures (SOPs), employee codes of conduct, internal investigations, and self-reporting;
  • Informed consent, institutional review board (IRB) approval, and clinical trial registration and reporting;
  • Pharmaceutical, medical device, food, and dietary supplement advertising and promotion;
  • Change reporting and supplemental application requirements for drugs and medical devices;
  • OTC monograph requirements for drug product formulation and labeling;
  • Product safety monitoring and adverse event reporting;
  • Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP);
  • Product formulation, labeling, and claims including permissible product ingredients, health claims, nutrient content, and “structure/function” claims for foods and dietary supplements;
  • Food Safety Modernization Act compliance, involving hazard analysis, preventive control and corrective action plans, supplier verification programs, track-and-trace, and recordkeeping requirements; and
  • Import and export requirements, international trade (customs and country-of-origin matters, European Union (EU) regulation and policies).

News & Insights

News & Insights