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50.5621 CFR Ch. I (4104 Edition)(f) Permission by parents or guardians must be documented in accordance with and to the extent required by 50.27. (g) When the IRB determines that assent is required,
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What is title 21 - us?
Title 21 - US refers to the Code of Federal Regulations governing Food and Drugs.
Who is required to file title 21 - us?
Manufacturers, distributors, and packers of food and drugs are required to file title 21 - US.
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Title 21 - US can be filled out electronically through the FDA's electronic submission system.
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The purpose of title 21 - US is to ensure the safety and proper labeling of food and drugs in the United States.
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Information such as product ingredients, manufacturing processes, and labeling must be reported on title 21 - US.
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