FDA Guidelines for Host Cell Proteins in Biopharmaceuticals

FDAFDA stands for Food and Drug Administration (also called USFDA). The FDA is a federal agency of the United States Department of Health and Human Services.

The scope of FDA’s regulatory authority is very broad. The FDA’s organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations. FDA’s responsibilities are closely related to those of several other government agencies.

Subset of products regulated by the FDA

Drugs, including:

  • prescription drugs (both brand-name and generic)
  • non-prescription (over-the-counter) drugs

Biologics, including:

  • vaccines
  • blood and blood products
  • cellular and gene therapy products
  • tissue and tissue products
  • allergenics

More information on the FDA Homepage