Description

Regulation and Development Fast-track NDA (New Drug Application) reviews and permission for limited off-label use are examples of steps the FDA has taken to make vital medicines more readily available to the patient population. However, as this week’s Learning Resources illustrate, these policies are fraught with risk. To prepare for this Discussion, review the steps that the FDA has taken to accelerate the approval of new drugs and devices and consider both the positive and negative consequences, as described in this week’s Learning Resources. By Day 4, post a comprehensive response to the following: • In general, should the FDA adopt a liberal (increased risk) or conservative (increased safety) approach to approving medical products and why? • What effect will the regulatory approach you endorse have on the development, manufacturing, and marketing of these products? • How well have the incentives provided by the Orphan Drug Act worked? Are they justified and adequate for addressing rare disorders? Include specific examples to support your arguments. include an example!!!!!!!

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