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The FDA slapped a Boynton Beach, Fla., clinical investigator with a warning letter after his staff mistakenly recorded patients’ pain intensity scores and relief assessments. Read More
The European Medicines Agency is lending support to an initiative to qualify biomarkers that can provide early warning of an investigational compound’s risks of causing drug-induced kidney injuries. Read More
New FDA requirements regarding emergency research on incapacitated patients stress that sponsors must attempt to get permission from the patient’s family to continue a trial that was started without consent and allow patients to opt out once they are conscious. Read More
Drug and device manufacturers would have to submit all clinical trial data to the federal government — including data for products never approved by the FDA — under a massive, proposed expansion of data collection. Read More
The EU ombudsman is questioning the European Medicines Agency’s claim that it wasn’t violating any laws when it allowed AbbVie to redact information from clinical study reports. Read More
German regulators have published a list of 80 generic medicines whose approvals were yanked after EU authorities expressed concerns with contract research organization GVK Biosciences. Read More
Sponsors submitting pediatric study plans for a drug have several options to determine optimal dosing for children when no standard dosing information exists, according to an FDA draft guidance on clinical pharmacology in pediatric studies. Read More
Sponsors of multi-site clinical trials should take greater advantage of their ability to use a single institutional review board, says a draft policy that seeks to require the practice for all NIH-supported domestic trial sites. Read More
India’s Central Drugs Standard Control Organization is seeking industry feedback on a draft of accreditation and ethics standards that it expects from clinical trial sites, investigators and ethics committees. Read More
Amgen pulled the plug on its experimental stomach cancer drug rilotumumab after data from two late-stage clinical trials raised serious safety concerns, marking the company’s second failed cancer drug this month. Read More
As part of an initiative to increase clinical trial transparency, the FDA has launched a website that provides information about the sex, age, race and ethnicity of participants in studies that support drug approvals. Read More
Merck has gained exclusive licensing rights to an experimental Ebola vaccine that is still undergoing clinical trials under a deal with NewLink Genetics. Read More