(iii) Include complex scientific issues or (ii) Set forth changes in interpretation or policy that are of more than a minor nature (i) Set forth initial interpretations of statutory or regulatory requirements (c) What other terms have a special meaning? (1) "Level 1 guidance documents" include guidance documents that: (3) Guidance documents do not include: Documents relating to internal FDA procedures, agency reports, general information documents provided to consumers or health professionals, speeches, journal articles and editorials, media interviews, press materials, warning letters, memoranda of understanding, or other communications directed to individual persons or firms. (2) Guidance documents include, but are not limited to, documents that relate to: The design, production, labeling, promotion, manufacturing, and testing of regulated products the processing, content, and evaluation or approval of submissions and inspection and enforcement policies.
(b) What is a guidance document? (1) Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency's interpretation of or policy on a regulatory issue. (a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.
Subpart B - General Administrative Procedures PART 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES The information on this page is current as of Jun 07, 2023.įor the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
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