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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
Sanofi has decided to stop pursuing regulatory filing for its blood cancer drug fedratinib after new safety concerns arose from several clinical trials. Read More
CDER Director Janet Woodcock said Nov. 15 that she supports the creation of a swift-approval pathway for antibiotics that target limited patient populations. 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
Clinical investigators need to improve adherence to study protocols and maintain better records of their trials, according to findings from an FDAnews-sponsored study. 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