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

In this question, (A) is true.

As an agency created under administrative law, FDA can make changes to the Food Drug and Cosmetic Act through rule making

The United States Federal Food, Drug and Cosmetic Act (FFDCA/FDCA/FD&C) is the laws passed by United State Congress in 1938. The authority of this section was given to US Food and Drug Administration (FDA) for the safety measures of food, cosmetic, drugs, medicines, and such other materials. The regulations are governed by US congress and interpreted by FDA. Title 21 of the Code of Federal Regulations (21 CFR) governs food and drugs within US for the FDA, DEA and ONDCP whereas Title 45 of CFR is for the public welfare by the department of health and human services. New guidance’s should follow Good guidance practices and 21 CFR for guideline agenda and then publicly released for notice-and-comment rulemaking.

The FDA requirements for informed consent are the minimum basic elements of informed consent that must be presented to a research subject [21 CFR]  the additional protections at 45 CFR mentioned. Regulations have to comply all the way of the law

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