Why do post-marketing drug studies required by the FDA take so long?

Forbes

10 September 2019 - Often times when a new drug is approved by the FDA, the agency requires more studies be done with the drug despite the fact that it has been already approved for sale. 

This is especially true for drugs that have been given accelerated approval. These are usually drugs that have been approved for serious or life-threatening diseases where the patient need is acute. 

However, in some instances the FDA often wants more data, usually longer patient exposure, to ensure that any risks posed by the drug are outweighed by its benefits.

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Michael Wonder

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Michael Wonder