General Biologics Guidances
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.
- Administrative Guidances
- Adverse Events and Product Deviation Guidances
- Application Submissions Guidance
- Biosimilars Guidances
- Clinical Guidances
- CMC and GMP Guidances
- Devices Guidances
- Generics Guidances
- Labeling and Promotion Guidances
- Resources for You