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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
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
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
Several EU member states suspended marketing authorization for therapies that underwent bioequivalence testing at contract research organization GVK Biosciences’ facility in Hyderabad, India, citing serious concerns about deviations from good clinical practice. Read More
Clinicians, bioethicists and regulators disagree over whether or not some patients in Ebola drug trials should be given placebos, and the debate is pitting the FDA against some international organizations.
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Clinical trial sponsors and contract research organizations incur the majority of good clinical practice violations, a European Medicines Agency panel reports. Read More
Indian authorities issued a number of clinical trial regulations last month, covering compensation for trial injuries, exemptions for local Phase III trials and penalties for conducting trials without permission. Read More