Investigational products include which of the following?

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Multiple Choice

Investigational products include which of the following?

Investigational product means the substance whose safety and efficacy are being studied in a clinical trial. Vaccines and biological products fall squarely into this category because they are the kinds of substances that are tested in trials to determine their effects in people, including when they are tested for a new indication or route of administration, even if some related products are already authorized for other uses. Over-the-counter supplements and cosmetics aren’t typically the investigational product in a trial; they’re regulated differently and aren’t the primary substances studied for a new therapeutic effect in GCP trials. Medical devices are handled under a separate category (investigational devices) when studied in trials, not as investigational products in the same sense as drugs or biologics. So vaccines and biological products are the correct choice.

Investigational product means the substance whose safety and efficacy are being studied in a clinical trial. Vaccines and biological products fall squarely into this category because they are the kinds of substances that are tested in trials to determine their effects in people, including when they are tested for a new indication or route of administration, even if some related products are already authorized for other uses.

Over-the-counter supplements and cosmetics aren’t typically the investigational product in a trial; they’re regulated differently and aren’t the primary substances studied for a new therapeutic effect in GCP trials. Medical devices are handled under a separate category (investigational devices) when studied in trials, not as investigational products in the same sense as drugs or biologics. So vaccines and biological products are the correct choice.

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