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The European Medicines Agency wants biosimilars makers to use pharmacodynamic markers alongside pharmacokinetic data to demonstrate biosimilarity. Read More
Clinical investigators in India could face up to five years in jail for studies that violate the country’s clinical trial regulations, under draft legislation released in late December by the Department of Health and Family Welfare. The prospect could further hinder India’s clinical trials industry, one expert says. 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
Sponsors and investigators will share responsibilities for gathering and reporting clinical trial information on clinicaltrials.gov, if a November proposed rule is finalized. Read More
The FDA warned a Phoenix, Ariz., clinical investigator for confusing audiometry reports for patients taking part in a clinical study of Purdue Pharma’s hydrocodone bitartrate painkiller. Read More
A new, first-of-its-kind clinical trial quality system created by CRO Analytics could help sites and sponsors track enrollment months earlier than conventional methods, experts say. Read More
Experience levels of principal investigators fluctuate wildly the world over, a fact that could put promising research at risk, according to a Tufts University report on protocol noncompliance rates and principal investigator turnover. Read More
An industry panel agreed Jan. 29 that industry stakeholders need to agree on a set of standards that should be part and parcel of investigators’ good clinical practice training. Read More
Drugmakers should notify the European Medicines Agency within 10 days of receiving an initial opinion on a pediatric investigation plan if they plan to request another review. 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
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