Shifting evidence collection from pre-approval to the post-market setting successfully brings new therapies to patients sooner, but at a cost in safety evaluation, researchers conclude in an analysis published online Oct. 28 in JAMA Internal Medicine.
“The testing of new drugs has shifted from a situation in which most testing was conducted prior to initial approval to a situation in which many innovative drugs are more rapidly approved after a small trial in a narrow patient population, with extensive additional testing conducted after approval,” state
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