Author: Smoak, Carey G.

Source: Pharmaceutical Programming, Volume 3, Number 1, June 2010 , pp. 12-15(4)

Publisher: Maney Publishing

Abstract:

Medical devices and diagnostics are increasingly important to the healthcare industry. The number of devices approved by the FDA has increased by 52% in the past decade. While devices are important in and of themselves, they are also increasingly more and more important in pharmaceutical research including diagnostic imaging used to monitor therapies, devices used to deliver drugs and diagnostic tests to determine if a patient will respond to a particular therapy. Devices are different from pharmaceutical products in terms of the FDA approval process, the use of CDISC standards and types of studies.

Keywords: CDISC; STUDIES; APPROVAL; DEVICE; DIAGNOSTIC

Document Type: Research Article

DOI: http://dx.doi.org/10.1179/175709310X12765117447327

Affiliations: Roche Molecular Systems, Inc., 4300 Hacienda Drive, Pleasanton, CA 94588, USA;, Email: carey.smoak@roche.com

Publication date: 2010-06-01

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