Navigation Links
ReGen to FDA: 'Thanks, But No Thanks'
Date:3/22/2011

l year, included a second, unprecedented, Advisory Panel Meeting, and culminated in the decision that the device had a different intended use.  According to this decision, ReGen's surgical mesh, despite its similarity to approved meshes, would not be regulated as a surgical mesh pursuant to 510(k)but instead would be treated as a novel Class III device.  Dr. Shuren has stated his intention to "rescind" the FDA's original 510(k) clearance – an unprecedented step that has unsettled the FDA regulatory community.  Dr. Bisbee states: "It's unbelievable that after more than five years of 510(k) review of this product -- and after being told by the ODE Director and the CDRH Director to file two separate 510(k) submissions for this device as a surgical mesh -- Dr. Shuren now says that they were wrong.  This arbitrary and unsubstantiated intention is an example of why the investment community is increasingly wary of investing in companies with products requiring FDA approval."

In opting out of the FDA's Part 16 hearing, ReGen put the agency on notice that it will seek an unbiased review of Menaflex's approval status under U.S. law.  "We and they both know the agency has no legal authority to rescind its clearance of Menaflex.  There is ample evidence the FDA completely botched its review of our Collagen Scaffold at every stage," said Dr. Bisbee. "After six years of unthinkable bias, mistakes and blunders, we are opting out of the FDA's administrative process and pursuing other legal options for continuing to market Menaflex to U.S. orthopedic surgeons and their patients."

The FDA's decision that device clearances can be re-reviewed and rescinded long after they have been approved will chill U.S. investors' enthusiasm for investing in the development and distribution of new devices, although a wide range of medical product innovations are desperately needed here and abroad. 

About ReGen Biologics, Inc.


'/>"/>
SOURCE ReGen Biologics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
2. ImmuneRegen BioSciences Reports Material Transfer Agreement with VaxGen, Inc.
3. ImmuneRegen BioSciences, Inc. Demonstrates Radilex(TM) Increases Disease-Fighting White Blood Cells
4. Tengion Launches Second Phase 2 Clinical Trial of Regenerated Human Organ
5. Acologix Presents Preclinical Data on Cartilage Regeneration by AC-100 at the OARSI 2007 World Congress on Osteoarthritis
6. Ceregene Presents Long-term Follow-up From Phase 1 Trial of CERE-120 in Parkinsons Disease
7. Tengion Launches Third Phase 2 Clinical Trial of Regenerated Human Bladder
8. Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
9. Preclinical Data Demonstrate Ability to Regenerate an Entire Bladder With Tengion Neo-Bladder Replacement(TM)
10. Tengion Scientists Publish Key Preclinical Findings Demonstrating the Benefits of Organ Regeneration Vs. Repair
11. International Team Locates Key Player in Muscle Regeneration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2015)...  Regulatory leaders in the pharmaceutical industry continue to ... "21 st Century Cures." This ... by Congress soon and if enacted into law, it ... developed and marketed in the United States ... to consider how the proposed changes could impact their ...
(Date:4/17/2015)... 17, 2015 Nonin Medical, a global leader ... Chief Operating Officer Steve Bucholz will retire ... expanding his role as Chief Executive Officer. In addition, ... Technology Officer. Operations will transition to David Noel ... has been instrumental to Nonin Medical,s growth," Mr. ...
(Date:4/17/2015)... DUBLIN , Apr. 17, 2015 Research and ... addition of the "Medical Equipment Rental and Leasing ... offering. This report analyzes the worldwide markets ... The report provides separate comprehensive analytics for the US, ... , and Rest of World. Annual estimates ...
Breaking Medicine Technology:21st Century Cures: A Regulatory Game-Changer for the Pharmaceutical Industry 2Nonin Medical's Philip Isaacson Expands CEO Role; President and COO Steve Bucholz to Retire May 1 2Medical Equipment Rental and Leasing Market 2015-2020 - Global Strategic Business Report - Healthcare Spending Slowdown Bodes Well for Medical Equipment Leasing 2
... today launched a new program to help county residents deal ... with the National Association of Counties (NACo), the free Prescription ... offers an average of 24 percent savings off the retail ... be used by those who do not have insurance or ...
... Perrigo Company (Nasdaq: PRGO ; TASE) today ... quarter fiscal 2012 on Thursday, October 27, 2011 at approximately ... at 10:00 a.m. (ET) hosted by Joseph C. Papa, Perrigo,s ... will be available live via webcast to interested parties on ...
Cached Medicine Technology:Yamhill County Introduces Prescription Discount Card to Help Alleviate High Costs 2
(Date:4/19/2015)... (PRWEB) April 19, 2015 Family and friends ... for Brains in Memory of Brad Baddeley event to ... Aneurysm Foundation. , Bowling for Brains is cheduled to take ... 4700 Dudley Street in Lincoln, Nebraska. Participants may arrive at ... to 3:00pm. , The cost is only $4 per game ...
(Date:4/18/2015)... has released a new blog post explaining that ... a car accident. , Car insurance policies can ... can pay for car repairs and even medical expenses ... coverage when they are driving. , An ... riders that offer extra coverage options. One of the ...
(Date:4/18/2015)... 18, 2015 Review of Ophthalmology magazine ... ‘Strategies for Success’ program for cataract surgeons attending the ... San Diego, where eye surgeon Jeffrey L. Martin, MD ... event. Dr. Martin is the Managing Partner of North ... chose Dr. Martin to lead this year’s discussion on ...
(Date:4/18/2015)... York (PRWEB) April 18, 2015 Thousand ... filed on behalf of individuals who were allegedly harmed ... continue to move forward in the U.S. District Court, ... April 10th, the Court has amended an earlier Case ... cases. Among other things, the new amendment permits the ...
(Date:4/18/2015)... “ ArcAngel ” was featured on NewsWatch as part ... latest and coolest applications on the market for ... and technology expert, conducted the app review and shared with ... In a turbulent world, people may find themselves in dangerous ... their first move, but some situations can be avoided if ...
Breaking Medicine News(10 mins):Health News:Lincoln, NE’s Bowling for Brains to benefit Renowned Brain Aneurysm Foundation 2Health News:Lincoln, NE’s Bowling for Brains to benefit Renowned Brain Aneurysm Foundation 3Health News:Auto Insurance Plans Can Cover Physical Injuries Caused By An Accident! 2Health News:Dr. Jeffrey Martin Invited to Share Latest Breakthroughs in Cataract Care During Roundtable Discussion at National 2015 ASCRS Meeting In San Diego 2Health News:DePuy Pinnacle Hip Lawsuits: Federal Litigation Amends Case Management Order to Allow for Joinder of Unrelated Claims 2Health News:DePuy Pinnacle Hip Lawsuits: Federal Litigation Amends Case Management Order to Allow for Joinder of Unrelated Claims 3Health News:A Personal Safety Application was Featured on NewsWatch Television 2
... vaccine to,prevent shingles was approved for use in 2006, ... age 60 and older who,previously had chickenpox. But two ... primarily affects adults with weakened immune,systems -- have left ... This uncertainty prompted a group of researchers led by,Barbara ...
... SWEDESBORO, N.J., Dec. 12 Yesterday, the U.S. ... vacated the Drug Enforcement,Administration,s (DEA) 2006 revocation of ... been challenging the DEA,s,decision since it first was ... company,s appeal of the,DEA,s decision and the DEA,s ...
... of trouble was 2 to 4 times greater than with ... -- Infants delivered by elective Caesarean section are up to ... born vaginally or by emergency C-section, says a Danish study ... British Medical Journal . , Researchers analyzed data on 34,000 ...
... (Dec. 12, 2007) -- Weill Cornell Medical College has ... & Melinda Gates Foundation to help fight tuberculosis, an ... kills nearly two million yearly -- mostly in the ... developing innovative TB drugs that are more effective than ...
... Officials Will Explain Regulatory Plans for Cutting-Edge,Technology at National ... 12 Nanotechnology was,incorporated into more than $50 billion ... 2014, the market will grow to $2.6 trillion.,By 2011, ... be,sold -- up from more than $3 billion in ...
... Dec. 12 Research that delivers,winning practices for improving ... management - is now available in the Best,Practice Database, ... Best Practices, LLC., To review sample key findings ... page with links to each study at this address:, ...
Cached Medicine News:Health News:Mayo Clinic Proceedings Article Offers New Data About the Impact of the Shingles Virus on Healthy Adults 2Health News:Mayo Clinic Proceedings Article Offers New Data About the Impact of the Shingles Virus on Healthy Adults 3Health News:Wedgewood Pharmacy: U.S. Court of Appeals Vacates DEA Action 2Health News:Wedgewood Pharmacy: U.S. Court of Appeals Vacates DEA Action 3Health News:Wedgewood Pharmacy: U.S. Court of Appeals Vacates DEA Action 4Health News:Elective Caesareans Raise Risk of Breathing Problems in Newborns 2Health News:Weill Cornell receives $2.4 million in grants from Gates Foundation to fight tuberculosis 2Health News:Weill Cornell receives $2.4 million in grants from Gates Foundation to fight tuberculosis 3Health News:Food and Drug Law Institute, Project on Emerging Nanotechnologies Co-Sponsor Major Conference on Nanotechnology Law, Regulation and Policy 2Health News:Food and Drug Law Institute, Project on Emerging Nanotechnologies Co-Sponsor Major Conference on Nanotechnology Law, Regulation and Policy 3Health News:Food and Drug Law Institute, Project on Emerging Nanotechnologies Co-Sponsor Major Conference on Nanotechnology Law, Regulation and Policy 4Health News:Best Practice Database Adds New Research on Contract Management and New Product Development 2
The design of this table top is based on advanced functionality for specific urological requirements. This composite product sets a new standard for urological imaging....
... The Hydra Vision® Plus DR Urology System ... It is the first dedicated digital urology ... the DR was designed to use optimized ... (16") image intensifier for maximum anatomical coverage ...
... KCIs AirMaxxis™ is a pressure relief mattress overlay ... air loss therapy for those patient with skin ... ,INDICATIONS: , Patients whose body weight and ... issue to the patient or staff during the ...
... A Bariatric bed providing a flexible ... pressure relief mattress system for comfort, support, ... weighing up to 850 lbs. ,Large patients ... patient using a static mattress that would ...
Medicine Products: