regen
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Biologics
ReGen Biologics appeals loss to FDA
April 9, 2014 by Brad Perriello ReGen Biologics asks a federal appeals court to overturn its loss of a lawsuit filed against…
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Biologics
FDA makes ReGen 510(k) rescission final
ReGen Biologics Inc. reiterates its plan to seek regulatory and legal options for marketing its Menaflex knee implant, which the…
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Recon
ReGen Turns Down FDA Hearing on Rescinding Knee Implant Clearance
WASHINGTON, March 22, 2011 /PRNewswire/ — ReGen Biologics, Inc. (ReGen), manufacturer of the popular and successful Menaflex Collagen Meniscus implant, today declined…
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Regen Biologics slams FDA for revoking Menaflex approval
Regen Biologics blasted the Food and Drug Administration Monday for its decision to revoke its 2-year-old approval of the company’s…
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FDA Rescinds Approval of Menaflex Knee Replacement Device
The FDA has rescinded approval for the Menaflex Collagen Scaffold knee replacement, saying that the orthopedic implant was incorrectly fast-tracked…
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FDA: ReGen’s Menaflex data inadequate
The Food & Drug Administration said ReGen Biologics Inc. (OTC:RGBO) failed to produce adequate evidence that its Menaflex knee implant…
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FDA Wrestles With Undoing Decision
WASHINGTON—The Food and Drug Administration is struggling to determine whether it has authority to re-evaluate a knee device that it…
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