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 UK’s cost-effectiveness agency plans to seek access to clinical trial data from European regulators if drug companies fail to supply relevant information, according to an updated process guide for developing technology appraisal recommendations.
The Department of Justice has closed its civil investigation into alleged data falsification in a clinical trial for AstraZeneca’s heart drug Brilinta, a move that clears the way for the drug to potentially reach blockbuster status. Read More
Evaluations of diagnostic test accuracy studies should include separate meta-analysis of positive and negative likelihood ratios, according to a draft guideline by the EU Network for Health Technology Assessment. Read More
Institutional review boards that assume oversight of a clinical trial from another IRB should give drugmakers an opportunity to address any concerns the receiving IRB has with the study before it is terminated or suspended, an FDA final guidance says. Read More
European drugmakers are praising the clinical trials regulation advancing through the EU Parliament, with the continent’s largest pharma group saying it will dramatically improve the efficiency of clinical studies. Read More
A UK coalition of drugmakers and a cancer research group are launching an analysis of failed Phase III lung cancer drug trials that will search for treatments that, despite failing overall, are effective for certain subpopulations. Read More
Sponsors that use surrogate endpoints, such as biomarkers, in confirmatory cancer trials may need to provide postmarketing data to verify that the information used to gain marketing authorization in the EU remains valid in practice. Read More
FDA inspectors berated a clinical investigator at New York’s Columbia University Medical Center for failing to properly oversee a clinical trial, despite the university having shut down the study after discovering the violations. Read More