FDA: friend or foe?
Delays in FDA product approvals have weakened the US medical device market. Reduced investment returns and the erosion of industry's confidence in FDA procedures have slowed the introduction of new products and threatened the market's potential for growth. This article examines the background to those issues and describes FDA's attempts to overcome its procedural shortcomings.
Lewis
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Medical Device Consultancy, Cardiff, UK. trevor@lewlink.demon.co.uk
D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods; D006801:Humans; D011050:Policy Making; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000639:trends