Reality check for device-drug convergence
Article Abstract:
The medical device industry is excited about the notion of drug-device convergence technology, which would impact the world of biology and engineering related to health care products and drugs. Some of the early convergence products, which have attained multi-billion-dollar sales in just over three years, include first-generation 'soft devices' that use an artificial matrix to deliver regenerative proteins.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2007
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A turbulent year at the agency
Article Abstract:
The year 2005 was the most politically charged year by all accounts in recent memory at the United States Food and Drug Administration (FDA). The fundamentals of reviewing drugs for approval started, by all accounts without any slowdown in the overall development and approval with FDA approving its stamp on eight biotech drugs in 2006, in line with the number from the past few years.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2006
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Looking for solid ground along the critical path
Article Abstract:
The Food and Drug Administration has entered into a partnership with Arizona-based Critical Path Institute (C-Path) to develop new tools to promote drug safety and accelerate drug developments. A profile of C-Path, which boost of success in initiating the warfarin program and the first Preclinical Safety Testing Consortium, is presented.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2006
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