Wyoming MPJE (Pharmacy Jurisprudence) Practice Exam

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What is the main function of the FDA's post-marketing safety system?

  1. Detecting serious unexpected adverse events

  2. Promoting generic drug development

  3. Reviewing clinical trial methodologies

  4. Updating ingredient lists for approved drugs

The correct answer is: Detecting serious unexpected adverse events

The main function of the FDA's post-marketing safety system is to detect serious unexpected adverse events. This system helps monitor the safety of drugs and medical devices once they are on the market, focusing on identifying any adverse effects that were not evident during the pre-market approval process. Detecting these unexpected adverse events is crucial for ensuring the ongoing safety and effectiveness of pharmaceutical products available to the public. On the other hand, options B, C, and D are not the primary functions of the FDA's post-marketing safety system.