"d. Studies in combination or as monotherapy
For a drug known to be effective as monotherapy, a single adequate and well-controlled study is usually sufficient to support effectiveness of the drug when combined with other therapy (as part of a multidrug regimen or in a fixed-dose combination). Similarly, known effectiveness of a drug as part of a combination (i.e., its contribution to the effect of the combination is known) would usually permit reliance on a single study of appropriate design to support its use as monotherapy, or as part of a different combination, for the same use. For example, a single study of a new combination vaccine designed to demonstrate adequate immune response will ordinarily provide sufficient evidence of effectiveness if the new combination contains products or antigens already proven to be effective alone or in other combinations. These situations are common for oncologic and antihypertensive drugs, but occur elsewhere as well."
"Substantial evidence was defined in section 505(d) of the Act as “evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.”
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