Enactment of Which of the Following Major Federal Drug Regulations

question 11

Multiple Choice

Enactment of which of the following major federal drug regulations required that new drug products be proven both safe and effective before they could be approved for sale in the U.S.?

• A) Federal Food,Drug,and Cosmetic Act (FD&C Act),1938
• B) Comprehensive Drug Abuse Prevention and Control Act (Controlled Substances Act),1970
• C) Durham-Humphrey Amendment to the FD&C Act,1951
• D) Kefauver-Harris Amendment to the FD&C Act,1962

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Definitions:

Common Stock

Common stock represents ownership shares in a corporation, giving holders voting rights and a share in the company's profits through dividends.

Par Value

A nominal value assigned to share of stock in the charter of a corporation, unrelated to market value.

Legal Expense

Costs incurred in the process of legal advice, litigation, or other legal services.

Paid-In Capital

Funds raised by a company through the sale of its shares to investors, over and above the par value of these shares.