Device Firms Criticize FDA Proposals To Share More Pre-Market Intel

Article preview from "The Gray Sheet" -July 26, 2010

Device and drug makers say FDA's draft proposals for publicly releasing more information on product applications would cripple the industry without providing much benefit to patients.

Device Firms Criticize FDA Proposals To Share More Pre-Market Intel

By  Jessica Bylander

Device and drug makers say FDA's draft proposals for publicly releasing more information on product applications would cripple the industry without providing much benefit to patients. But other groups say the agency's "transparency" proposals do not go far enough. In May, FDA proposed 21 policy changes aimed at increasing access to information on regulated products to help the public better understand agency decisions and to provide more data to doctors and patients. To read this article in its entirety, purchase this article online or get it FREE when you subscribe to "The Gray Sheet". Plus: To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Kristy Kennedy at (480) 985-9512