FDA required studies of approved drugs make a big difference for public health

FDA

7 December 2017 - Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be both effective and safe for use if prescribed according to its labelling. 

However, there may be issues that need additional evaluation after approval. For example, post-approval studies may be needed to confirm clinical benefit when a drug is approved under accelerated approval provisions. Additionally, post-approval studies can allow for further evaluation of a potential safety issue or better characterise risk factors for a known safety issue. 

Once a drug is approved, a larger population and wider range of patients will use the drug than were studied before approval. With this larger experience, new potential safety issues may emerge that were not seen in the studies prior to approval, and such issues may require additional evaluation.

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Michael Wonder

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Michael Wonder