Do the FDA provide guidance documents?

Guidance documents represent FDA’s current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

How are biologics regulated by the FDA?

Biological products are a subset of drugs; therefore both are regulated under provisions of the FDC Act. However, only biological products are licensed under section 351 of the PHS Act. (As previously noted, some therapeutic protein products are approved under section 505 of the FDC Act, not under the PHS Act.)

What are FDA guidance documents?

What is guidance? Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency’s interpretation of or policy on a regulatory issue.

What do you need to know about biologics guidance?

Biologics Guidances 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.

When did the FDA release the biological evaluation guidance?

On June 16, 2016 the FDA officially released the much anticipated Guidance Document Titled: Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” Guidance for Industry and Food and Drug Administration Staff.

Where can I find the FDA biologics rules?

Proposed & Final Rules specifically related to biologics are organized by biologics product area. Cross-Center and Office of the Commissioner Proposed and Final Rules are posted in a general FDA Rules section.

What is the purpose of a FDA guidance document?

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.