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The European Medicines Agency appears to be backing off promises to protect industry trade secrets in its new clinical trials database, and is developing scenarios under which it would release commercially confidential information. Read More
Trials of drugs targeting complicated intra-abdominal infections should use only drugs that are standard of care as active comparators, the FDA says, and studies should minimize the use of outside antibiotics in trial subjects as much as possible to produce clear, definitive trial results. Read More
The European Medicines Agency appears to be backing off promises to protect industry trade secrets in its new clinical trials database, and is developing scenarios under which it would release commercially confidential information. Read More
Mobile health programs can unburden clinical trial sponsors and investigators by streamlining procedures, eliminating unnecessary activities and reducing site visits, according to GlaxoSmithKline and Medidata. Read More
In two years’ time, manufacturers must submit applications for NDAs, ANDAs, INDs and BLAs using a set of approved electronic formatting standards, which the FDA finalized last month. Read More
The Institute of Medicine is calling on clinical trial sponsors and governments to develop plans for substantially greater sharing of clinical trial data. Read More
Drug industry groups are urging the European Commission to invest more in research and development, streamline regulatory systems and accelerate recently approved clinical trial reforms as ways to bolster the EU’s pharmaceutical industry. Read More
The FDA is requesting industry feedback on the burdens related to its regulation of clinical safety and efficacy trials of unapproved new drugs and biologics. Read More
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
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
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
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