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.
European drug companies and transparency advocates alike are praising the clinical trials legislation advancing through the EU Parliament, with Europe’s largest pharma lobbying group saying the proposal as it now stands will dramatically improve clinical trial efficiency in the EU. Read More
GlaxoSmithKline has launched a new research partnership designed to help improve the targeting of new drugs in development, a signal that manufacturers may be growing more comfortable divulging clinical trials data. Read More
The European Medicines Agency plans to move forward with a controversial clinical trial transparency plan, but with new added redaction features to remove trial data that could allow companies to steal commercially confidential information. Read More
Northwestern University may have withheld information during a Senate probe on the use of an unapproved heart device, a key lawmaker claims in a new letter to the university and its hospital. Read More
India’s Ministry of Health and Family Welfare has begun publishing data about drugmakers’ payouts in cases where clinical trial subjects died during a trial. The first wave of data focuses on payouts between 2010 and 2013. Read More
The FDA and India’s Ministry of Health and Family Welfare signed a five-year accord that will allow them to share information from clinical trial inspections in their respective jurisdictions. Read More
Drugmakers in the EU are pushing back against a proposal moving through the EU Parliament that would grant clinical trial participants the right to demand that their trial data — including data shared between regulators and other entities — be deleted. Read More