This collection contains documents from Drug Approval Packages generated by the US Food and Drug Administration (FDA). The collection currently contains documents regarding two drug classes - antipsychotics and antidepressants.
The FDA review documents made available in this digital repository formed the basis for an article entitled Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database. Eight second-generation antipsychotic drugs are covered. The Drug Approval Package for one of the drugs (risperidone) is not available for download from the FDA website Drugs@FDA, but it is available here. The other seven Drug Approval Packages can be downloaded from the FDA website. Unfortunately, the FDA makes these documents available in a format that can be difficult to navigate (see related article)—for example, they cannot be searched for text words. Here, in the interest of making these important documents more accessible to the public and to researchers, we have applied optical character recognition to them, so that they are now searchable. For additional enhancements, please see the methods section of the above-linked article.