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U.S. Department of Health and Human Services


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Part 2: Is The FDA Maintaining The Quality Of Its Premarketing Reviews?

Table of Contents: Managing the Risks from Medical Product Use: Creating a Risk Management Framework

Previous Section : Conclusions

Commissioner Jane Henney, as one of her first initiatives, created this Task Force to investigate concerns being expressed by critics and to look into the Agency's role in managing risk. She asked the Task Force to determine if the Agency was maintaining adequate quality control (QC) over its premarketing review decisions. To address this, the Task Force focused this part of its evaluation on the following:

  • Has there been an increase in the rate of unanticipated serious adverse events from medical products that have gone on the market subsequent to PDUFA?
  • How well is the Agency's QC system for premarketing review and marketing decisions functioning?
  • Are there any factors that could be affecting the Agency's ability to detect potential risks during its premarketing review?

Next Section : Has the rate of Serious Adverse Events increased?