Guidance, Compliance & Regulatory Information (Biologics)
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 Rules
- Other Recommendations for Biologics Manufacturers
- General Biologics Guidances
- Allergenics Guidances
- Blood Guidances
- Cellular & Gene Therapy Guidances
- Tissue Guidances
- Vaccine and Related Biological Products Guidances
- Xenotransplantation Guidances
- Advisory Committee Guidance Documents
- Clinical Trials Guidance Documents
- Combination Products Guidance Documents
- Guidances (Drugs)
- Import and Export Guidance Documents
- Click the following link to go to the Search for FDA Guidance Documents page
- Scroll down to the FDA Organization Guidance Document Search Filter and select Center for Drug Evaluation and Research from the dropdown list
- Use the Topic Filter option to select one of the following ICH guidance document topic filter options:
-
ICH-Efficacy
-
ICH-Multidisciplinary
-
ICH-Quality
-
ICH-Safety
Paragraph Header
Contact Us
White Oak Campus
10903 New Hampshire Ave
Silver Spring, MD 20993
United States
For Latest Updates Follow
@FDADrugs
The latest information from the Center for Biologics Evaluation and Research.