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REGEN BIOLOGICS, INC. v. SEBELIUS et al

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Case overview

Case Number:

1:11-cv-01006

Court:

District Of Columbia

Nature of Suit:

Other Statutory Actions

05:0706 Judicial Review of Agency Actions

Judge:

Rudolph Contreras

Firms

Government Agencies

  1. April 29, 2013

    After Win, FDA May Backtrack On More Device Approvals

    Earlier this month, a federal judge backed the U.S. Food and Drug Administration's decision to revoke its marketing clearance for a knee implant more than two years after it had initially granted it, a ruling that attorneys worry may embolden the agency to make similar retractions on other medical devices.

  2. March 14, 2013

    FDA Says It Caved To Politics In Clearing ReGen Implant

    The U.S. Food and Drug Administration said Thursday it had acted within its authority when it rescinded marketing clearance for a ReGen Biologics Inc. knee implant — an action the company says drove it into bankruptcy — because the device had gotten initial approval only due to "severe political pressure."

  3. June 1, 2011

    ReGen Sues FDA Over Menaflex Clearance Repeal

    ReGen Biologics Inc. sued the U.S. Food and Drug Administration in Washington on Tuesday, alleging that the agency's rescission of marketing clearance for its Menaflex collagen meniscus implant was unlawful and ultimately forced the company into bankruptcy.