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Tag: fda

Stem Cells, FDA, and the Edge of Science: Three Expert Viewpoints

Akillas | February 21, 2012
Stem Cells, FDA, and the Edge of Science: Three Expert Viewpoints

Gergana Koleva Contributor Join the forum discussion on this post

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Minutes from Negotiation Meeting on MDUFA III Reauthorization

Akillas | June 22, 2011
Minutes from Negotiation Meeting on MDUFA III Reauthorization

April 13, 2011 FDA – Industry MDUFA III Reauthorization Meeting Purpose To discuss potential financial baselines for device process funding under MDUFA III, as well as discuss FDA’s proposal package. Join the forum discussion on this post

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ReGen Sues FDA Seeking Restoration Of Knee-Device Approval

Akillas | June 22, 2011
ReGen Sues FDA Seeking Restoration Of Knee-Device Approval

ReGen Biologics Inc. (RGBOQ) has sued the U.S. Food and Drug Administration while seeking to restore approval for a knee-repair device. The FDA recently rescinded its prior approval for the key ReGen product, called Menaflex, blocking the company’s access to the U.S. market. Although the FDA cleared that device in December 2008, the agency determined [...]

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GAO renews critique of FDA medical device system

Akillas | April 19, 2011 | 0 Comments
GAO renews critique of FDA medical device system

WASHINGTON (AP) — Government investigators say the Food and Drug Administration is putting patients at risk by approving sensitive medical devices such as hip joints and heart defibrillators under the same streamlined system intended for power wheelchairs, stitches and catheters. The Government Accountability Office told Congress Wednesday that the approvals remain a serious issue for [...]

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