The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
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
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
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.
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.
Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age, as more women than men suffer from migraines, according to FDA draft guidance on trial design expectations for the pain drugs. Read More
Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age early in the drug development process, as more women than men have the condition, according to a new FDA draft guidance. Read More
Drug sponsors should find a more comprehensive way of recording and integrating patient outcomes data into their efficacy analyses, says a top FDA official who notes the lack of such data often presents a roadblock to making regulatory decisions. Read More
Researchers looking to study the safety and effectiveness of medical devices should tailor their trials to the requirements of the specific technology, a report by the Dutch Royal Academy of Sciences concludes. Read More