Drugs and Devices

Fenton Nelson advises clients on compliance with Food and Drug Administration (FDA) issues specific to healthcare providers.  Many providers are unaware of the extent to which the FDA regulates medical and healthcare practice.  In recent years, the FDA has become increasingly active in investigating and taking enforcement action against healthcare providers, often seeking criminal sanctions for unintentional violation of FDA laws.  Fenton Nelson's experience with FDA regulatory compliance includes:

• Defending civil and administrative investigative actions by FDA and state licensing agencies concerning alleged violations of FDA requirements for importation, purchase, and use of medications

• Counseling clients on "off label" use of drugs and devices

• Counseling clients on compliance with the federal Food, Drug, and Cosmetic Act requirements with respect to manufacturing, sale, and marketing of cosmeceutical products

• Advising Institutional Review Board (IRB) research compliance in connection with scientific research involving human research subjects and responding to research investigations

• Advising clients on Internet prescribing requirements

• Advising clients on compliance with FDA regulations specific to ESRD (dialysis centers) and responding to investigations of dialysis centers

• Advising clients on compliance with FDA regulations specific to mammography