U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. Guidance, Compliance & Regulatory Information (Biologics)
  4. Biologics Guidances
  1. Guidance, Compliance & Regulatory Information (Biologics)

Search all FDA Guidance Documents

Guidance documents describe FDA’s interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies. Guidance documents are not regulations and alternative approaches may be chosen to comply with laws and regulations.

Should you find a link that does not work within any Guidance document, Rule or other document posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA.

Recently Issued Guidance Documents


Biologics



Summary Document Issue Date FDA Organization regulated product taxonomy hidden Topic old hidden Topic Guidance Status Open for Comment Comment Closing Date on Draft Docket Number Guidance Type hidden center taxonomy hidden

Subscribe for CBER Updates

Get e-mail updates on What’s New at CBER!

Back to Top