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Cases Required for FDA Approval Decisions in Case of Insufficient Evidence

(HealthDay)-One study found that for U.S. Food and Drug Administration applications that went through multiple review cycles because evidence of clinical efficacy was initially considered inadequate, when assessing the evidence for approval. There is no mechanism or citation tradition to find similar cases. Published online on September 21st Annual report of internal medicine..

The FDA noted that approval criteria are flexible in the context of life-threatening illnesses and unmet treatment needs, Perrine Janiaud, Ph.D., School of Medicine, Stanford University, California. And colleagues reviewed new drug applications and biopharmacy approvals. Applications submitted between 2013 and 2018 were initially considered to have insufficient evidence of clinical efficacy, so multiple applications were submitted. Has gone through the review cycle of.

Overall, 117 of the 912 reviews reviewed went through multiple review cycles.Of these, only 22 faced additions review, Primarily due to issues related to clinical efficacy. Researchers found that the general basis for initial rejection included concerns about endpoints, the clinical significance of the observed effects, and inconsistent outcomes. Approval did not require new evidence, but required a new interpretation of 7 of the 22 original evidences. None of the FDA’s decisions cite the inferences used in previous decisions.

“The custom logic and procedures that the FDA follows to handle such situations have not been formally constructed on the basis of prior decisions, which is inefficient and consistent,” the author writes. “The FDA should expect its own database of decisions to allow rapid retrieval of cases with similar evidence characteristics and context, and the FDA authorities to cite previous decisions in decision notes.”


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Cases Required for FDA Approval Decisions in Case of Insufficient Evidence

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