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Research Letter
May 10, 2018

Fulfillment of Postmarketing Requirements to the FDA for Therapies Granted Oncology Indications Between 2011 and 2016

Author Affiliations
  • 1Cardinal Health Specialty Solutions, Cardinal Health, Dublin, Ohio
JAMA Oncol. Published online May 10, 2018. doi:10.1001/jamaoncol.2018.0610

The US Food and Drug Administration (FDA) attempts to strike a balance between approving newer therapies expeditiously while assuring that patients consuming these products are not harmed with unrecognized adverse events.1 The rapidity of approving novel agents in oncology allows patients access to potentially lifesaving therapies and incentivizes investigators in academic and pharmaceutical industries to continue clinical research efforts. The FDA strives to mitigate the risk of early market entry through the use of an accelerated approval (AA) program by requiring postmarketing studies.

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