Discussion 5 The FDA reviews New Drug Applications (NDAs) based on both the quality of

Discussion 5 The FDA reviews New Drug Applications (NDAs) based on both the quality of clinical data and the clarity of documentation in Modules 2-5. • If an NDA has well-written and well-organized Modules 2-5 but weak clinical data, what do you think the FDA’s decision should be? • Conversely, if the NDA contains strong clinical data but poorly written and disorganized Modules 2-5, how might that impact the FDA’s review process and final decision? • What key factors should be considered in both situations when determining the likelihood of approval? Think about how both scientific evidence and regulatory documentation quality influence drug approval.

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