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A San Diego, Calif.-based clinical researcher received an FDA warning letter over its lack of documentation of standard operating procedures for overseeing studies and details of in-service protocol and specimen handling training in a Form 483 response. Read More
Drugmakers are seeking clarification on the use of in vitro studies to assess the effects of active pharmaceutical ingredients taken by men on their potential offspring. Read More
A first-of-its-kind “basket study” of responses to Daiichi Sankyo and Genentech’s Zelboraf on a host of cancer mutations is showing positive results, Memorial Sloan Kettering Cancer Center researchers report. Read More
All sponsors planning to conduct clinical trials in Saudi Arabia for the first time must register their studies through the Saudi Clinical Trials Registry, under new guidance released in late August. Read More
A new study looking at large-scale clinical trials funded by NIH shows the number reporting positive results dropped precipitously in the years since they were required to preregister on the clinicaltrials.gov website. Read More
Biologics makers developing drugs based on bacteria and viruses should conduct preclinical and clinical studies to determine if infection could be unintentionally transmitted from treated patients to other individuals, the FDA says. Read More
HHS on Sept. 2 proposed an overhaul of human research subject protections, including simpler informed consent forms, informed consent for secondary research using biospecimens and using a single IRB for all domestic sites in multisite clinical trials. Read More
A decline in spending on clinical research following implementation of the Physician Payment Sunshine Act could change the clinical trial landscape if it becomes an ongoing trend, an expert warns. Read More
Companies developing drugs for rare diseases that lack alternative treatments may be able to start clinical trials without the standard toxicology studies, provided they justify the approach, the FDA says. Read More
The European Medicines Agency is declaring that six classes of diseases occur in children, forcing drugmakers to conduct pediatric tests prior to approval. Read More
Drugmakers developing treatments for diabetic and idiopathic gastroparesis should study those patient populations in separate trials, the FDA says. Read More
When using social media to recruit trial participants with rare diseases, it is important for sponsors to earn their trust by sharing general disease and trial knowledge before pitching a specific trial, an expert says. Read More