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A lack of diversity in clinical studies can have crucial health implications in minority populations, as medicines are launched with little understanding of genetic interactions, researchers and regulators warn. Read More
Over the past decade, the number of privately funded clinical trials has nearly doubled, while the number of government-sponsored studies have fallen, according to a new report from Johns Hopkins University. Read More
The FDA is recommending that drugmakers create safety assessment committees and formalized surveillance plans to watch for serious adverse events in clinical trials to decide when safety data should be unblinded. Read More
The FDA has delayed BioMarin’s plans to market drisapersen, the company’s Duchenne muscular dystrophy candidate, with a complete response letter calling for more evidence of the therapy’s benefits. Read More
Following the 2014 Ebola outbreak, the FDA is weighing the best options for testing and rapidly deploying treatments for emerging infectious diseases and wants to hear from you on the subject. Read More
Drugmakers need to better connect their clinical and R&D operations to cope with the growing cost and complexity of clinical trials amidst declining drug approvals. Read More
Roughly a fifth of cancer clinical trials fail to recruit enough participants, creating a “major barrier to progress” for developing new therapies, according to a paper published in the Journal of the National Cancer Institute. Read More
With an eye toward patient-focused drug development, the FDA is seeking feedback on a compilation of diseases and outcome measures gathered together under a new pilot program. Read More
Robert Califf, President Barack Obama’s choice to head the FDA, is calling for clinical trial reform, but does not believe new regulations are needed. Read More
Titan Pharmaceuticals won positive news from an FDA advisory committee Jan. 12, with panelists voting in favor of approving its implant to treat opioid addictions. Read More