Abstract
Post-marketing studies are undertaken to delineate additional clinical
information concerning a drug' s risks, benefits, and optimal use. Industry
stakeholders acknowledge that research undertaken in order to obtain marketing
authorization (MA) does not always coincide with initiatives to ensure that
the product is subsequently placed in its ideal or intended market context.
Such postmarketing data can therefore prove invaluable to governing bodies
like the FDA and EMEA, institutional payors and health authorities, and also
to the pharmaceutical companies themselves for strategic purposes.
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