FDA

Nelson Hardiman advises healthcare providers regulated by the Food and Drug Administration (FDA) including pharmaceuticals, medical devices, nutritional supplements, health treatments and cures. As the go-to law firm for healthcare law, we deliver the ideal combination of regulatory experience and forward-thinking to advise clients on compliance with FDA issues specific to healthcare providers.

Our knowledge and experience with FDA regulations and compliance protects providers wading into this vast and highly-regulated space. We counsel on every aspect of FDA regulations, concerning the safety of drugs, medical devices, food, cosmetics and other health-related products. Our singular focus and industry experience in healthcare and life sciences laws and regulations protects our clients from the threat of FDA investigations, and puts them ahead of the competition.

Our Work Includes:

  • Cosmeceutical Products Counseled several clients on compliance with the federal Food, Drug, and Cosmetic Act requirements with respect to manufacturing, sale, and marketing of cosmeceutical products.
  • Dialysis Center Advised on compliance with FDA regulations specific to ESRD (dialysis centers) and responded to an investigation of a dialysis center.
  • Institutional Review Board (IRB) Advised on compliance regarding scientific research involving human research subjects and responded to research investigations.
  • Mammography Counseled on compliance with FDA regulations specific to mammography.
  • Off-Label Drug and Medical Devices Counseled clients on “off label” use of drugs and devices.