In the context of marketing a new drug, which of the following is the significance of the 1997 Food and Drug Administration (FDA) Modernization Act?
A) It required advertisements for prescription drugs (mostly in medical journals) to contain a summary of information about adverse reactions to the drug.
B) It included the requirement that companies seek approval of any testing to be done with humans before clinical trials are conducted.
C) It included the guidelines for annual postmarketing reporting by the companies of adverse reactions to some medications.
D) It tightened the procedures whereby drug company salespeople could provide free samples to physicians.
Correct Answer:
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