Lammers et al. Blood Cancer Journal (2017) 7:637 DOI 10.1038/s41408-017-0008-9 Blood Cancer Journal CORRESPONDENCE Open Access Time from US Food and Drug Administration approval to publication of data for cancer drugs: a comparison of ﬁrst and subsequent approvals 1 2 1 1,3,4 Austin Lammers ,RuibinWang , Jeremy Cetnar and Vinay Prasad In 1993, the Omnibus Budget Reconciliation Act required ﬁrst and subsequent approvals in order to assess for this the Centers for Medicare and Medicaid Services (CMS) to difference. If there were less incentive to seek subsequent pay for off-label cancer drugs if supported by one of the approvals, the average time from publication (used for ﬁve compendia, which over time has come to include that compendia inclusion) to approval would be longer. of the National Comprehensive Cancer Network To do this, we ascertained all US FDA hematology and (NCCN) . Estimates suggest that 30% of cancer drug use oncology anti-cancer drug approvals from the FDA in the United States (US) is off-label, amounting to annual website: http://www.fda.gov/Drugs/InformationOnDrugs/ costs of nearly 5 billion dollars in 2010 . Typically, these ApprovedDrugs/ucm279174.htm from 2010 to 2014. We cancer drugs are initially approved for one indication, but once supported by a compendium;
Blood Cancer Journal – Springer Journals
Published: Nov 30, 2017
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