What is 21cfr 50?

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What is 21cfr 50?

(a) This part applies to all clinical in- vestigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support ap- plications for research or marketing permits for products regulated by the Food and Drug …

What part of the 21 CFR speaks to the requirements for the protection of human subjects?

PART 50 — PROTECTION OF HUMAN SUBJECTS The authority citation for 21 CFR part 50 continues to read as follows: Authority: Secs. 201, 406, 408, 409, 502, 503, 505, 506, 507, 510, 513-516, 518-520, 701, 706, 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

What does CFR FDA stand for?

Food and Drug Administration
The FDA stands for the Food and Drug Administration, the federal agency concerned with public health. The number 21 is the section which governs Food and Drugs in the United States and the CFR stands for the Code of Federal Regulations.

What is the purpose of 21 CFR Part 11?

What is 21 CFR Part 11? CFR stands for “Code of Federal Regulation.” 21 CFR Part 11, in particular, details the criteria under which electronic records and signatures are considered to be trustworthy and equivalent to paper records.

How often is the CFR published?

once each calendar year
It is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis.

What type of IRB review does not require approval?

“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.

What is FDA in research?

The US Food and Drug Administration (FDA) regulates clinical studies conducted on drugs, biologics, devices, diagnostics, and in some cases dietary supplements and food additives.

Who does 21 CFR part 11 apply to?

Coverage. Practically speaking, Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions.

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