Search for FDA Guidance Documents
You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and ...
Guidances | FDA
Guidance documents describe FDA’s interpretation of or policy on a regulatory issue (21 CFR 10.115 (b)).
Guidance Documents (Medical Devices and Radiation-Emitting …
What is guidance? Guidance documents are prepared for the FDA’s staff, regulated industry, and the public to describe the FDA’s interpretation of or policy on a regulatory issue.
Guidances | Drugs | FDA
Jan 17, 2025 · FDA guidance documents discuss the production, labeling, manufacturing of regulated products and denote FDA's current thinking and policy interpretation.
FDA Guidance Documents: General and Cross-Cutting Topics
Topics found in this search include guidance on advisory committees, clinical trials and good clinical practice, combination products, imports and exports, administrative and procedural processes ...
Clinical Trials Guidance Documents | FDA
Guidance documents listed below represent the agency's current thinking on the conduct of clinical trials, good clinical practice and human subject protection.
Guidance documents are documents prepared for FDA staff, regulated industry, applicants/sponsors, and the public that describe the Agency’s interpretation of, or policy on, a regulatory issue.5 ...
OCMO Guidance Agenda | FDA
Jan 13, 2025 · The Office of the Chief Medical Officer (OCMO) is sharing the following lists of guidance documents for public review and input: Guidance documents we intend to publish in …
The purpose of this guidance document is to provide an overview of the mechanisms available to submitters through which they can request feedback in writing or during a meeting with the Food and ...
OCMO Guidance Documents | FDA
Jan 13, 2025 · Guidance documents describe the FDA’s interpretation of, or policy on, a regulatory issue (21 CFR 10.115 (b)).