What did the Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act do?
A) Created the Food and Drug Administration FDA)
B) Required that certain drugs be made available over-the-counter.
C) Strengthened requirements for safety and efficacy studies before drugs were approved.
D) Created the first registry of adverse drug events.
Correct Answer:
Verified
Q5: During which phase of the drug approval
Q6: At what point in the drug approval
Q7: All three phases of clinical testing of
Q8: Which of the following is a problem
Q9: Which of the following statements is true
Q11: During which phase of the drug approval
Q12: A spontaneous reporting system - a passive
Q13: Pharmacoepidemiology is the application of epidemiological reasoning,
Q14: In pharmacoepidemiology, the term effectiveness is used
Q15: Assessing exposure in post-marketing Phase IV) drug
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