Try our Advanced Search for more refined results
- Law360
- Law360 UK
- Law360 Pulse
- Law360 Employment Authority
- Law360 Tax Authority
- Law360 Insurance Authority
- Law360 Real Estate Authority
- Law360 Healthcare Authority
- Law360 Bankruptcy Authority
- Products
- Lexis®
- Law360 In-Depth
- Law360 Podcasts
- Rankings
- Regional Powerhouses
- Law360's MVPs
- Women in Law Report
- Law360 400
- Diversity Snapshot
- Practice Groups of the Year
- Rising Stars
- Titans of the Plaintiffs Bar
- Sections
- Adv. Search & Platform Tools
- About all sections
- Browse all sections
- Banking
- Bankruptcy
- Class Action
- Competition
- Employment
- Energy
- Expert Analysis
- Insurance
- Intellectual Property
- Product Liability
- Securities
- Beta Tools
- Track docs
- Track attorneys
- Track judges
REGEN BIOLOGICS, INC. v. SEBELIUS et al
Case Number:
1:11-cv-01006
Court:
Nature of Suit:
Judge:
Government Agencies
-
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.
-
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The U.S. Food and Drug Administration said Thursday it had acted within its authority when it rescinded marketing clearance for a ReGen Biologics Inc. knee implant — an action the company says drove it into bankruptcy — because the device had gotten initial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."
-
June 01, 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.