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Device and diagnostics makers 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
Drug and biologic makers would have to submit all clinical trial data to the federal government — including data for products not approved by the FDA — under a massive proposed expansion of data collection. Read More
Companies developing vaginal microbicide gels to prevent HIV infections should have a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue in human studies evaluating the safety and tolerability of the products, says a new final guidance. Read More
The FDA Monday issued new requirements for emergency research on incapacitated patients, stressing that sponsors must search for a patient’s family to seek permission to continue any trial started without consent and allow patients to opt out once they’re conscious. Read More
European regulators yesterday told the European Union ombudsman that they adhered to the law when allowing manufacturer AbbVie to redact information from its clinical study reports, marking the latest twist in the debate over European trial data transparency. Read More
The European Medicines Agency has lent its support to an initiative to qualify biomarkers that can provide an early warning on an investigational compound’s risks of causing drug-induced kidney injuries, an endorsement that researchers say is necessary to move to the next phase of development. Read More
Health Canada wants sponsors of cell therapy products to conduct preclinical studies either in vitro or in animals to address potential risks and delivery issues before initiating human trials of the products. Read More
Access to a forthcoming clinical trials portal and database would be limited to authorized users and “super users,” under draft specifications released by the European Medicines Agency.
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The UK’s Health Research Authority is proposing a set of scaled-back procedures for obtaining informed consent from patients in simplified pragmatic research trials. Read More
The FDA is working on a number of projects designed to lower clinical trial costs and speed up trial times, a top FDA official told conference-goers at the Society for Clinical Research Sites’ 2014 Site Solutions Summit. Read More
Sponsors seeking to enroll patients in studies of treatments for invasive aspergillosis may use the presence of the molecule galactomannan as a probable indicator of the infection, under an FDA program to qualify biomarkers used in drug development.
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Drug sponsors need to find more thoughtful, comprehensive ways of recording and integrating patient outcomes data into their efficacy analyses, but long questionnaires may not be the solution, a top FDA official says.
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