PPLE MODULE 2 questions with correct answers

The sulfanilamide elixer tragedy of 1937 resulted in the government passing the Food, Drug and Cosmetic Act (FDCA) of 1938 that specified which one of the following: CORRECT ANSWER That new drugs must have FDA approval prior to marketing Which of the following accurately describe(s) the FDA today? CORRECT ANSWER The agency regularly relies on advice from outside experts The agency is housed under DHHS A manufacturer of an industrial solvent promoted that its product when applied to the skin would cure eczema, but specifically proclaimed that its product is a solvent, not a drug. The FDA is investigating whether the product should be considered as a drug. Which of the following would be the best answer regarding the claim to cure eczema. CORRECT ANSWER The claim to cure eczema would likely make the product a drug and the proclamation is irrelevant Assume in the above example that the manufacturer made no claim or representation about its product for the use in eczema, but rather a consumer accidently found it effective for treating eczema and advertised this result on the Internet. Which would be correct? CORRECT ANSWER The FDA would not likely regard the product as a drug Part C of the drug definition excludes food from articles intended to affect the function or structure of the body. Congress likely intended which of the following by this exclusion: CORRECT ANSWER Th