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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
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
The European Medicines Agency is launching a 12-month pilot program to improve the usefulness of postmarket safety data by providing drugmakers with targeted advice on postmarket study design. Read More
Sponsors of new drug applications in China must submit comprehensive data showing adherence to clinical trial requirements by Aug. 25 — in a surprise move that could prompt noncompliant or unprepared companies to withdraw their applications, reducing a pending backlog of more than 1,600. Read More
The Critical Path Institute has formed the Global Pediatric Clinical Trials Network Pre-Launch Consortium to facilitate treatments for infants, children and adolescents — a top FDA priority. Read More
Drugmakers developing treatments for diabetic and idiopathic gastroparesis should study those patient populations in separate trials, the FDA says. Read More
Companies developing therapies that may have an adverse effect on the testes should conduct clinical trials to pin down the toxicity and whether it is reversible, the FDA says. Read More