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.
Videotapes of patients giving informed consent to participate in clinical trials must show the investigator explaining the study protocol in language the subject can understand, according to a draft guideline by India’s Central Drugs Standard Control Organization. Read More
The FDA’s Center for Devices and Radiological Health is working on ways to permit sponsors to use more adult clinical trial data in proving the safety and effectiveness of pediatric medical devices. Read More
The IRB at a major Chicago hospital has been handed an FDA warning letter for a slew of violations in a device clinical trial, many of which were first observed at the site over a decade ago. Read More
A new data standard being proposed by the Clinical Data Interchange Standard Consortium could give sponsors and FDA reviewers greater flexibility to analyze data, if adopted by the agency for drug review applications. Read More
Johnson & Johnson unveiled a first-of-kind clinical trial data-sharing plan that it hopes will become a model for industry transparency initiatives: rather than provide direct access to trial data, sponsors could contract with third parties to serve as gatekeeper and approve data access requests. Read More
As the FDA moves to update and standardize data submission standards for NDAs, ANDAs, INDs and BLAs, it’s warning sponsors they will only have two years to come into compliance once guidance is finalized later this year. Read More
Sponsors of vaccine trials intended to support a marketing submission in China have seven days to report study-related fatalities and another eight days to file follow up reports, according to a new China Food and Drug Administration guideline. Read More