What Are Guidance Documents?

Guidance documents describe FDA’s interpretation of applicable Center’s policy (e.g., FDA CBER) 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.

Guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statue, regulations, or both.

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.

Recently Issued Guidance Documents

Read more from FDA/CBER here >>

General Guidance in Biologics

  • Administrative
  • Adverse Events and Product Deviation Guidances
  • Application Submissions Guidance
  • Clinical Guidances
  • CMC and GMP Guidances
  • Devices
  • Labeling and Promotion

Download FDA Good Guidance Practice Regulations


Your Name

Enter Your Email to Download (Required)

Last Date Updated:  April 8, 2015