More scrutiny for approved drugs

Studies completed following the introduction of new drugs are on the rise, potentially leading to a more complete understanding of risks and benefits, according to a new report.

These so-called post-market studies, once done on a voluntary basis, were made mandatory in 2007. Since then, according to a report published in the Journal of the American Medical Association, the percentage of postmarket studies completed has nearly doubled, from 6.6 percent to 12.6 percent.

Researchers tied the higher compliance number to passage of the Food and Drug Administration Amendments Act, which empowered the FDA to require postmarket studies during the drug-approval process.


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