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Post FDA-approval drug safety data: why they are vital and how they can be made accessible, actionable, and predictable

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Side effects from drugs, vaccines, and devices approved by the Food and Drug Administration (FDA) are a major public safety concern.

Due to financial and logistical hurdles, no pre-approval clinical trial can ever be large enough, or long enough, to identify and properly characterize all side effects that may occur once a drug is introduced to large consumer populations.

All FDA approved drugs have the potential to trigger various side effects not revealed during pre-approval investigations. Careful and continuous post-approval monitoring is therefore vital to the evaluation of a drug's safety profile.

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