Which of the following is true: A. ) As an agency created under administrative l

Question

Which of the following is true:

A. ) As an agency created under administrative law, FDA can make changes to the Food Drug and

Cosmetic Act through rule making.

B.) The relevant regulations for FDA are not just found in 21 CFR but also 45 CFR

C.) Guidances explain the law and regulations and the “advice” they provide is as binding as a

regulation.

D.) Regulations do not have the same enforceability as Statues, they are only one way to comply

with the law.

E.) New guidances must go through the same noticeandcomment rulemaking required of new

regulations

Explanation / Answer

A. ) As an agency created under administrative law, FDA can make changes to the Food Drug and

Cosmetic Act through rule making.

Note: By giving permission to FDA to make changes to the Food Drug and Cosmetic Act through rule making, the congress has speeded up the administrative processes.

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