In what year did Kefauver Harris Amendment require proof of safety and efficacy?

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Multiple Choice

In what year did Kefauver Harris Amendment require proof of safety and efficacy?

Explanation:
The key idea is that this amendment established that a drug must be proven safe and effective before it can be approved for marketing. Implemented in 1962 after the thalidomide tragedy, it closed the gap where safety data alone wasn’t enough. The change meant sponsors had to provide evidence of efficacy in addition to safety, and it also introduced stronger manufacturing controls, required informed consent for participants in trials, and mandated adverse-event reporting. So, the year when proof of safety and efficacy became required is 1962.

The key idea is that this amendment established that a drug must be proven safe and effective before it can be approved for marketing. Implemented in 1962 after the thalidomide tragedy, it closed the gap where safety data alone wasn’t enough. The change meant sponsors had to provide evidence of efficacy in addition to safety, and it also introduced stronger manufacturing controls, required informed consent for participants in trials, and mandated adverse-event reporting. So, the year when proof of safety and efficacy became required is 1962.

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