Biomaterial Database

FDA: friend or foe? 1996

T S Lewis

Medical Device Consultancy, Cardiff, UK. trevor@lewlink.demon.co.uk

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.

UI	MeSH Term	Description	Entries
D011050	Policy Making	The decision process by which individuals, groups or institutions establish policies pertaining to plans, programs or procedures.	Analysis, Policy,Policy Analysis,Policy Development,Analyses, Policy,Development, Policy,Developments, Policy,Making, Policy,Policy Analyses,Policy Developments
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D013997	Time Factors	Elements of limited time intervals, contributing to particular results or situations.	Time Series,Factor, Time,Time Factor
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D014486	United States Food and Drug Administration	An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.	Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration
D017277	Drug Approval	Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.	Drug Approval Process,New Drug Approval,Food and Drug Administration Drug Approval,Food and Drug Administration Drug Approval Process,New Drug Approval Process,Approval Process, Drug,Approval Processes, Drug,Approval, Drug,Approval, New Drug,Approvals, Drug,Approvals, New Drug,Drug Approval Processes,Drug Approval, New,Drug Approvals,Drug Approvals, New,New Drug Approvals,Process, Drug Approval,Processes, Drug Approval