ABOUT WOOD BURDITT

The Wood Burditt Group represents, counsels and advises clients in all matters of food and drug law. Our extensive practice covers administrative, regulatory and compliance matters under the United States Food and Drug Administration (FDA), Federal Trade Commission (FTC), Department of Agriculture (USDA), Centers for Medicare and Medicaid Services (CMS), Drug Enforcement Agency (DEA), Alcohol and Tobacco Tax and Trade Bureau, the Consumer Product Safety Commission and the U.S. Customs and Border Protection. Additionally, we represent clients at all levels of federal and state courts.

The Wood Burditt Group represents both public and private clients of all sizes, from start-ups to multinational corporations, in the food, pharmaceutical, medical device, cosmetic, and dietary supplement industries. We assist clients with pre-marketing requirements and product development, as well as post market compliance. Such issues include clinical investigation requirements, product approval and safety, Quality Systems Regulations (QSRs) and Good Manufacturing Practice Requirements (GMPs), regulatory strategies, product advertising & labeling, product importation / exportation, product liability, market protection strategies, and government enforcement.

EXPERIENCE

  • Numerous premarket clearances for medical devices.
  • FDA Inspections of drug and medical device manufacturers.
  • Importation and Exportation of FDA regulated products.
  • HIPAA issues for covered entities and business associates.
  • Successful petitions before the National Advertising Division.