To prepare, 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.
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.
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