Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs
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One of the key underlying issues facing the development of effective for their intended uses. all drugs, and particularly orphan drugs, is what kind of evidence the Food and Drug Administration (FDA) requires for FDA has for many decades acknowledged that there is a need approval. The Federal Food, Drug, and Cosmetic [FD&C] Act provides that for FDA to grant approval for a new drug, there ample, one of FDA’s regulations states that: “FDA will apmust be “substantial evidence” of effectiveness derived from prove an application after it determines that the drug meets the “adequate and well-controlled investigations.” This language, statutory standards for safety and effectiveness... While the which dates from 1962, provides leeway for FDA medical restatutory standards apply to all drugs, the many kinds of drugs viewers to make judgments as to what constitutes “substantial that are subject to the statutory standards and the wide range -