Broadened FDA Indication For GORE VIABAHN(R) Endoprosthesis For Iliac Occlusive Disease (Medical News Today)
W. L. Gore & Associates (Gore) announced it has received approval from the US Food and Drug Administration (FDA) to market the GORE VIABAHN Endoprosthesis for use in patients with symptomatic peripheral arterial disease in iliac artery lesions with reference vessel diameters ranging from 4.0 - 12.0 mm.

FDA Issues Warning Letters To Ranbaxy Laboratories Ltd., And An Import Alert For Drugs From Two Ranbaxy Plants In India (Medical News Today)
The Food and Drug Administration (FDA) issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India. The Warning Letters identify the agency's concerns about deviations from U.S.

CDISC Awarded Contract For Training Of FDA Reviewers (Medical News Today)
The Clinical Data Interchange Standards Consortium (CDISC), announced today that the Food and Drug Administration (FDA) selected CDISC, via a formal RFP process, to provide training to FDA reviewers of regulatory submissions.