This study assesses factors associated with regulatory approval or reasons for failure of investigational therapeutics in phase 3 or pivotal trials and rates of publication of trial results.
This study uses US Food and Drug Administration data to identify approved generic drugs manufactured between September 30, 1984, and January 11, 2016 and compares the effects of number of generic drugs associated with brand-name drugs.
This Viewpoint argues that the acceleration of the drug approval process could unequally distribute the costs and burdens of testing to vulnerable patient populations.
This systematic review and meta-analysis of randomized clinical trials assesses the efficacy and safety of flibanserin for the treatment of hypoactive sexual desire disorder in women.
This study reviewed transcripts of meetings of the Oncologic Drugs Advisory Committee to the US Food and Drug Administration to characterize potential financial and other conflicts of interest of public speakers.
This review of approvals of cancer drugs based on a surrogate end point by the US Food and Drug Administration assesses the postmarketing findings for overall survival.
This randomized trial explores why press releases with neutral terms—and that routinely explain the limited evidence supporting accelerating approval—might help consumers make more accurate judgments about drugs with “breakthrough” designation.
This Viewpoint describe the case of the commercial withdrawal of tositumomab as a cautionary tale of the weaknesses in our current drug-approval system.
To inform the debate about appropriate standards, Moore and Furberg studied the development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the US FDA in 2008. Carpenter provides an Invited Commentary.
This population-based study examines the association between use of incretin-based drugs in patients with type 2 diabetes and development of acute pancreatitis.