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FDA Medical Product Approvals: Hearing Before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight House of Representatives, One Hundred Fourth Congress, First S: Hearing Before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Ove

FDA Medical Product Approvals: Hearing Before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight House of Representatives, One Hundred Fourth Congress, First S: Hearing Before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Ove

          
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About the Book

Excerpt from Fda Medical Product Approvals: Hearing Before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight House of Representatives, One Hundred Fourth Congress, First Session, August 8, 1995

You will, no doubt, hear more about this aspect Of the problem from other testimony that you will hear today. Again, I emphasize that the greatest care is taken to ensure that these devices are safe and efficacious prior to their human application.

A Specific example Of our concerns relates to the coronary stent, a small, thin, metallic device that is permanently implanted into coronary arteries Of ill patients to hold these vessels Open. Only two types Of stents are currently available in the United States. Both devices were available to European patients long before they were available in the United States.

A current example Of this problem as it now stands relates to a new type Of stent that is coated with a drug. In the past, a small fraction Of these stents occluded causing potentially serious prob lems and an innovative solution has been developed by an Amer ican company that has pioneered this technology Of putting an anti quag, that is a drug, on the stent that prevents it from occluding. These devices are currently being tested across Europe. None Of them are available for use or testing in the United States.

These devices will not be available in this country, in fact, for many years; yet, there has been not one single record Of any Of these devices occluding in Europe.

The situation is Of great concern to us for Obvious reasons, thus. First and foremost, American patients do not have access to these life-saving devices, not proven quite efficacious and safe. Second, the problems in the application Of this new technology have impor tant downstream consequences. For example, as technology leaves the country, the excellence of our research, both in a clinical and basic context, suffers.

American researchers in medical devices are becoming followers rather than leaders as it relates to new device research. Jobs, ex pertise and leadership are thus continuing to leave this country.

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This book is a reproduction of an important historical work. Forgotten Books uses state-of-the-art technology to digitally reconstruct the work, preserving the original format whilst repairing imperfections present in the aged copy. In rare cases, an imperfection in the original, such as a blemish or missing page, may be replicated in our edition. We do, however, repair the vast majority of imperfections successfully; any imperfections that remain are intentionally left to preserve the state of such historical works.


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Product Details
  • ISBN-13: 9781331740902
  • Publisher: Forgotten Books
  • Publisher Imprint: Forgotten Books
  • Height: 225 mm
  • No of Pages: 66
  • Series Title: English
  • Weight: 104 gr
  • ISBN-10: 1331740908
  • Publisher Date: 05 Jan 2019
  • Binding: Paperback
  • Language: English
  • Returnable: N
  • Spine Width: 4 mm
  • Width: 150 mm


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FDA Medical Product Approvals: Hearing Before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight House of Representatives, One Hundred Fourth Congress, First S: Hearing Before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Ove
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FDA Medical Product Approvals: Hearing Before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight House of Representatives, One Hundred Fourth Congress, First S: Hearing Before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Ove
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FDA Medical Product Approvals: Hearing Before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight House of Representatives, One Hundred Fourth Congress, First S: Hearing Before the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Ove

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