The FDA Approval Process:

Does it hinder the availability of potentially beneficial drugs to the American public?

 

Over the past couple of decades the Food and Drug Administration has been criticized for the apparent slowness of the drug approval process. Some claim that the extensive time required for a drug to be approved for market allows many people to die that could have been saved by beneficial drugs that were held up in the approval process. In order to evaluate these claims, the approval process must be examined and important tradeoffs such as time vs. safety and benefits vs. risks must be addressed.

 

1. What is the Food and Drug Administration (FDA)?

2. Getting a drug approved

3. Benefits versus Risks

4. Time versus Safety

5.Examples

6. Conclusion

7. Links

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If you have any questions about this site or you have encountered a problem, you can e-mail Bruce Mackay, or Stacey Sheasley or Kristin Averill