![]() (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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