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Wrong ReGen Biologics?

ReGen Biologics

Reviewer

Food and Drug Administration

HQ Phone:  (888) 463-6332

Email: b***@***.gov

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I agree to the Terms of Service and Privacy Policy. I understand that I will receive a subscription to ZoomInfo Community Edition at no charge in exchange for downloading and installing the ZoomInfo Contact Contributor utility which, among other features, involves sharing my business contacts as well as headers and signature blocks from emails that I receive.

Food and Drug Administration

10903 New Hampshire Ave

Silver Spring, Maryland,20993

United States

Company Description

China's Food and Drug Administration (SFDA) is now offering a reward of about 50,000 US dollars for relevant information on counterfeit drug production. The bounty aims to "encourage the public to report illegal activities so as to determine, control and elimi...more

Background Information

Affiliations

Orthopedic Products Company

Board Member


HealthpointCapital LLC

Adds New Board Member


Proteus Inc

Adds New Board Member


Education

B.A.

biological science

Columbia College


Ph.D.


Web References(140 Total References)


ReGen Biologics Inc. Archives – MassDevice

www.massdevice.com [cached]

ReGen Biologics appeals loss to FDA
ReGen Biologics appeals loss to FDA ReGen Biologics' long battle against the FDA entered a new phase this year, with the medical device company's appeal in a lawsuit it filed against the watchdog agency, its top regulator and the secretary of the U.S. Health & Human Services Dept. over the FDA's decision to rescind the clearance granted to ReGen's Menaflex knee implant. FDA, ReGen Biologics ReGen Biologics Inc. (OTC:RGBO) terminated its common stock registration in connection with its bankruptcy proceedings connected to the FDA's rescission of 510(k) clearance for the company's Menaflex knee implant. Earlier this month ReGen sued the FDA, it's top regulator and the secretary of the U.S. Dept. of Health & Human Services, accusing them of overstepping their bounds in rescinding the clearance. Filed Under: Business/Financial News, Legal News, News WellTagged With: ReGen Biologics Inc. ReGen Biologics sues FDA over 510(k) rescission June 1, 2011 By MassDevice staffLeave a Comment ReGen Biologics, FDA FDA, ReGen Biologics ReGen Biologics Inc. (PINK:RGBO) filed for Chapter 11 bankruptcy protection with the U.S. Bankruptcy Court for the District of Delaware. FDA, ReGen Biologics ReGen Biologics Inc. (OTC:RGBO) is weighing options for the Menaflex knee implant the FDA forced off the market last week. The agency rescinded its 2008 510(k) clearance for the Hackensack, N.J.-based company's embattled bio-absorbable knee implant last October. Last month ReGen rebuffed an offer from the FDA for a final hearing on the decision. Filed Under: Food & Drug Administration (FDA), Implants, News WellTagged With: Knees, ReGen Biologics Inc. ReGen Biologics: We're too broke to file our annual report March 31, 2011 By MassDevice staffLeave a Comment FDA, ReGen Biologics


www.medcitynews.com

ReGen Biologics terminates stock after suing FDA
ReGen Biologics terminates stock after suing FDA ReGen Biologics terminates stock after suing FDA ReGen Biologics Inc. (OTC:RGBO) terminated its common stock registration in connection with its bankruptcy proceedings connected to the FDA's rescission of 510(k) clearance for the company's Menaflex knee implant. Earlier this month ReGen sued the FDA, its top regulator, and the secretary of the U.S. Department of Health & Human Services, accusing them of overstepping their bounds in rescinding the clearance. That decision came the same week that the FDAreleased a report saying ReGen failed to produce adequate evidence that device was safe before it was cleared to hit the market. ReGen Biologics terminates stock after suing FDA


www.medcitynews.com

ReGen Biologics terminates stock after suing FDA | Read more
ReGen Biologics terminates stock after suing FDA ReGen Biologics terminates stock after suing FDA ReGen Biologics Inc. (OTC:RGBO) terminated its common stock registration in connection with its bankruptcy proceedings connected to the FDA's rescission of 510(k) clearance for the company's Menaflex knee implant. Earlier this month ReGen sued the FDA, its top regulator, and the secretary of the U.S. Department of Health & Human Services, accusing them of overstepping their bounds in rescinding the clearance. That decision came the same week that the FDAreleased a report saying ReGen failed to produce adequate evidence that device was safe before it was cleared to hit the market. ReGen Biologics terminates stock after suing FDA


bizmology.hoovers.com

ReGen Biologics goes bankrupt after FDA yanks Menaflex approval
ReGen Biologics has filed for Chapter 11 bankruptcy protection - just one week after the FDA rescinded its approval of the company's Menaflex orthopedic implant device. The implant was originally approved in 2008, but it promptly [...] ' st_title='ReGen Biologics goes bankrupt after FDA yanks Menaflex approval' st_url='http://bizmology.hoovers.com/2011/04/12/regen-biologics-goes-bankrupt-after-fda-yanks-menaflex-approval/' displaytext='LinkedIn'> ReGen Biologics has filed for Chapter 11 bankruptcy protection - just one week after the FDA rescinded its approval of the company's Menaflex orthopedic implant device. The implant was originally approved in 2008, but it promptly became part of a congressional investigation into the FDA's review process in 2009. The CMS revoked Medicare reimbursement in 2010, and towards the end of the year the FDA concluded that the device's approval had been granted in error. The rescission was issued on March 30, 2011, and ReGen filed for bankruptcy a short nine days later. Though the implant has been sold in other countries in Europe and Africa for more than 10 years, ReGen must either conduct additional clinical trials or have the device reclassified before it can re-introduce Menaflex in the US market. The implant is a collagen matrix replacement for the meniscus (knee cartilage). After spending substantial funds on gaining FDA approval and building up a US commercial infrastructure, as well as on legal advice during the investigation process, it's no huge surprise that the company is broke. ReGen had yet to turn a profit on international product sales prior to the US launch, and it doesn't look like things will be looking up for the company anytime soon. Regardless, its faith in the Menaflex product offering appears to be unshaken. ReGen had refused the FDA's offer of a last hearing with the agency shortly before the rescission, stating that the FDA's decision was "unbelievable" and that it would pursue other legal channels to regain marketing approval for Menaflex. But with its bankrupt status, it seems to me that it will be difficult for the company to pursue legal action and improve its financial situation at the same time. Tags:cartilage, Chapter 11, CMS, device, FDA, FDA approval, health care, implant, investigation, knee implant, marketing approval, Medicare, Menaflex, meniscus, ReGen Biologics, rescinded, rescissionCategory:Buzzworthy, Health Care


www.wsbt.com

Specifically, between 2006 and 2008, FDA scientists repeatedly rejected a knee repair device from Regen Biologics, a company based in Hackensack, N.J. In a 2007 rejection letter to the company, an FDA reviewer said the company's device had "an increased risk" compared with products already on the market.
FDA scientists recommended rejecting another application from the company in fall 2008, saying Regen had not shown "that patients who received the device experienced any benefit."


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