ReGen Sues FDA Seeking Restoration Of Knee-Device Approval
02 6월 2011 - 4:35AM
Dow Jones News
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The FDA recently rescinded its prior approval for the key ReGen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 after a later review that the product didn't meet
criteria for the approval pathway that was used.
ReGen filed for Chapter 11 bankruptcy protection in April, days
after the FDA pulled approval for Menaflex. In a suit filed
Tuesday, the company said it seeks an order setting aside the FDA's
March 30 rescission letter.
That rescission move was "arbitrary, capricious, an abuse of
discretion and not in accordance with law," ReGen said in its
complaint, filed in the U.S. District Court for the District of
Columbia.
The Hackensack, N.J., company named the FDA and the heads of
that agency and the Department of Health and Human Service as
defendants. An FDA spokeswoman said the agency doesn't comment on
pending litigation.
ReGen wants the court to set aside the FDA's decision to pull
approval for Menaflex. The company also seeks a court judgment
declaring that its product can be legally marketed in the U.S., and
to recover costs and expenses including attorneys' fees.
The Menaflex product--a collagen-based surgical mesh used to
reinforce damaged or weakened soft tissue in knees--gained
marketing approval under the most commonly used FDA approval
pathway for medical devices. That process is intended for products
that are similar to already approved devices, but the FDA later
decided Menaflex was "technologically dissimilar from devices
already on the market."
The Wall Street Journal reported that 2008 approval came amid
political and lobbying pressure on the agency.
ReGen has said its product is safe and effective while
challenging the legitimacy of the FDA's review used to re-examine
its earlier decision. The FDA in January offered ReGen a chance to
request a hearing on the proposed approval rescission, but ReGen
declined in March while saying it would "seek an unbiased review of
Menaflex's approval status under U.S. law."
The FDA is engaged in a broad overhaul of its so-called 510(k)
device-approval process amid a mix of outside complaints that the
rules have been too lax and inconsistently applied.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com
ReGen Biologics (CE) (USOTC:RGBOQ)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
ReGen Biologics (CE) (USOTC:RGBOQ)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024