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

Guidance, Compliance & Regulatory Information (Biologics)

Guidance, Compliance & Regulatory Information (Biologics)

Image
Gavel resting on law book

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


Rules, Guidances & Recommendations

Compliance & Enforcement

Post-Market Activities

Forms


Related Information

 

Resources for You
Recalls & Alerts
Approvals & Clearances

Sub-Topic Paragraphs

Title
Follow CBER

Contact Point

Division of Manufacturers Assistance and Training
Office of Communication, Outreach and Development
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002

(800) 835-4709
(240) 402-8020

Hours Available

Food and Drug Administration
Food and Drug Administration
White Oak Campus

10903 New Hampshire Ave

Silver Spring, MD 20993
United States


For Updates on Twitter follow

Contact Point Twitter

@fdacber

The latest information from the Center for Biologics Evaluation and Research.


Subscribe for CBER Updates

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