Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 46

Drug safety in the US is covered under several sections of the Code of Federal Regulations (CFR). FDA regulations are consolidated in Title 21 of the CFR or 21 CFR (a searchable version of 21 CFR is available at www.regulations.gov).

21CFR312 covers INDs: 21CFR312.32 covers IND safety reports, including expedited 7- and 15-day reports. 21CFR33 covers IND annual reports. The NDA regulations for drugs are found in 21CFR314.80.

Updates to regulations are published in the Federal Register on a daily basis and are viewable (www.regulations.gov). Note that the consolidated CFR is only updated with the final FDA regulations from the daily Federal Register only once a year, on April 1^st. The Food, Drug and Cosmetic Act is available at https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/FederalFoodDrugandCosmeticActFDCAct/default.htm.