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 agency said the testimonials do not “adequately support the suggestion in the presentation that other patients switching to Livalo from other statins will experience a similar reduction in side effects.”
Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Monday it is relaxing those restrictions in line with its advisers’ recommendations. Read More
Indian authorities want clinical trial sites accredited and more heavily regulated. In a new report, a panel of advisors to the Ministry of Health and Family Welfare spells out specific reforms aimed at addressing past weaknesses in the country’s clinical investigation and drug approval processes. Read More
As drug sponsors make their way through the EU approval process, there are “triggers” that can help European Medicines Agency inspection coordinators determine whether a clinical trial should undergo a routine or for-cause good clinical practice inspection, an agency working group says. Determining factors include trial size, complexity and site selection. Read More
Investigators contemplating their own clinical trials need to understand the regulatory framework of investigator-initiated studies and what it means to be a sponsor investigator before wading into the water, a legal expert says. Read More
More and more pivotal clinical trials — typically Phase III studies — submitted in support of drug applications in Europe are being conducted outside of the region, a new report by the European Medicines Agency (EMA) finds. Read More