Search for FDA Guidance Documents
Search for official FDA guidance documents and other regulatory guidance.
Guidances | FDA - U.S. Food and Drug Administration
2024年12月2日 · FDA Centers and Offices publish annual Guidance Agendas, which list possible topics for future guidance document development or revision during the upcoming year. However, the guidance...
Guidances | Drugs | FDA - U.S. Food and Drug Administration
FDA guidance documents discuss the production, labeling, manufacturing of regulated products and denote FDA's current thinking and policy interpretation.
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
2024年8月30日 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 10.115 Good guidance practices. (a) What are good guidance practices? Good...
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
2024年8月30日 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). This database includes a codification of the general and permanent rules published in the...
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
2024年8月30日 · The information on this page is current as of Aug 30, 2024. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Subpart A - General Labeling...
eCFR :: 21 CFR Part 211 -- Current Good Manufacturing Practice …
(a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products (excluding positron emission tomography drugs) for administration to humans or animals.
Newly Added Guidance Documents | FDA
2024年10月30日 · Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.
FDA ruling limits which foods can be labeled 'healthy' on packaging
6 天之前 · Nearly a decade later, the FDA now says the updated "healthy" rule is in line with current U.S. dietary guidelines and "include a focus on the importance of healthy dietary patterns and the food ...
eCFR :: 21 CFR 10.115 -- Good guidance practices.
Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents. (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.