Submissions and Approvals

Indian Government Proposes Ambitious Clinical Trial Oversight Reforms

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

Roche Gets EU Approval Nod for Kadcyla

The European Commission has approved Roche’s Kadcyla to treat patients with HER2-positive locally advanced or metastatic breast cancer previously treated with Herceptin and/or a taxane. Read More