To the Editor: The Commentary by Dr O’Connor1 highlighted the importance of using publicly available US Food and Drug Administration (FDA) review documents in conducting independent assessments of the therapeutic value of new drugs. Many trials submitted to the FDA were recently found to be unpublished 5 years after new drug approvals.2 Accordingly, the information that is easily available in the published medical literature is incomplete and potentially biased.
Briefing documents are made available to the public prior to FDA advisory committee meetings. These documents contain early reviews of safety and efficacy data by agency scientists as part of the new drug approval process. A study by Nissen et al3 demonstrated the importance of accessing these documents before muraglitazar, the first dual peroxisome proliferator-activated receptor agonist, was marketed. In their analysis, the authors found the drug to be associated with excess major adverse cardiovascular events.
Although briefing documents may be more difficult to access than FDA new drug reviews,4 both must now be considered essential in conducting thorough reviews of the therapeutic value of new drugs.
Financial Disclosures: None reported.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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