Navigation Links
MiMedx Announces Next Steps After Discussions With The FDA
Date:12/4/2013

MARIETTA, Ga., Dec. 4, 2013 /PRNewswire/ -- MiMedx Group, Inc.  (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, provided an update today on its continuing discussions with the Food & Drug Administration (FDA) regarding the regulatory classification of its micronized products.  The Company received a communication from the FDA explaining the basis for the Agency's position regarding the micronized products.  The Company has responded to the FDA that while it does not agree with the Agency's position, it understands the Agency's interest in further regulating this emerging technology.  Accordingly, the Company has proposed to the FDA that it will pursue the Investigational New Drug (IND) and Biologics License Application (BLA) process for certain micronized products, and, in parallel, also proposed to enter into negotiations with the FDA on a plan to transition the micronized products to licensed biological products and continue to market the micronized products under specific conditions.  The Company has informed the FDA that it is ready to immediately commence discussions regarding this transition plan.  While there is no guarantee that the FDA would agree to any particular transition plan, the Company is hopeful that it can reach a mutually satisfactory agreement with the FDA in this regard. 

Parker H. "Pete" Petit, Chairman and CEO said, "We are pleased that the FDA has recently clarified its issue with our micronized products and has continued a dialogue with us to bring this matter to resolution.  We are in agreement with the Agency that this relatively new technology must enter the market in an orderly and safe manner with proper regulatory oversight.  A top priority for u
'/>"/>

SOURCE MiMedx Group, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. MiMedx Group to Present at the Stifel Nicolaus 2012 Healthcare Conference
2. MiMedx Group to Present at the 6th Annual OneMedForum
3. MiMedx Announces 2012 Results
4. MiMedx Group, Inc. Announces Release Date for 2013 Second Quarter Results
5. MiMedx Addresses FDA Untitled Letter And Reiterates 2013 And 2014 Guidance
6. MiMedx Announces Conference Call To Discuss FDA "Untitled Letter" And Reiterate Guidance
7. MiMedx to meet with FDA in Mid-October
8. Seven Poster Abstracts Highlight MiMedx Allografts at the 10th Annual Desert Foot Conference
9. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
10. Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012
11. JDRF Announces Research Collaboration with Dexcom, Inc. to Develop "Smart Transmitter" Technology to Accelerate Artificial Pancreas Studies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/1/2015)... KONG and FT LAUDERDALE, Florida ... Inc. ("OrbusNeich"), a designer, developer, manufacturer and marketer of innovative ... that on May 13, 2015, it prevailed in a final ... European Patent EP 1 341 482 - STENT HAVING HELICAL ... of review in the EPO and has been upheld as ...
(Date:7/1/2015)... , July 1, 2015  Imprimis Pharmaceuticals, Inc. ... on the development and commercialization of proprietary compounded ... ring The Nasdaq stock market closing bell on ... growing success of its Go Dropless™ campaign since ... cataract procedures are performed annually in the U.S. ...
(Date:7/1/2015)...  LabStyle Innovations Corp. (DRIO), developer of the ... of Todd Durniak as Senior Vice President and General ... over 20 years of medical device commercial and ... and General Manager of Neighborhood Diabetes, a division ... durable medical equipment (DME) and pharmacy channels with ...
Breaking Medicine Technology:OrbusNeich Announces Favorable Ruling from the European Patent Office and Initiation of Litigation Against Terumo Corporation 2Imprimis Pharmaceuticals to Ring The Nasdaq Stock Market Closing Bell 2Imprimis Pharmaceuticals to Ring The Nasdaq Stock Market Closing Bell 3Imprimis Pharmaceuticals to Ring The Nasdaq Stock Market Closing Bell 4LabStyle Innovations Appoints Senior VP & General Manager in U.S. for the Dario Diabetes Management Solution 2LabStyle Innovations Appoints Senior VP & General Manager in U.S. for the Dario Diabetes Management Solution 3LabStyle Innovations Appoints Senior VP & General Manager in U.S. for the Dario Diabetes Management Solution 4
... SILVER SPRING, Md., Oct. 7, 2011 The U.S. ... simvastatin), a fixed-dose combination (FDC) prescription medication that contains ... in adults who need both sitagliptin and simvastatin. ... million people in the United States have type 2 ...
... Oct. 7, 2011 ProteinSimple today announced plans ... service support for its biologics products in Europe, ... are included in this expanded support structure:  iCE ... systems. The biologics market segment is ...
Cached Medicine Technology:FDA Approves Combination Therapy Juvisync 2FDA Approves Combination Therapy Juvisync 3ProteinSimple to Offer Direct Sales, Service and Support for Biologics Products in Europe 2
(Date:7/1/2015)... NJ (PRWEB) , ... July 01, 2015 , ... ... , the global cancer enterprise of Hospital Corporation of America (HCA), as it ... and research, OncLive announced today. , With this new partnership, OncLive’s editorial ...
(Date:7/1/2015)... ... July 01, 2015 , ... Lisa Keys, the widow of U.S. Army Master ... Keys’ birthday) in memory of her late husband and all of America’s fallen military ... Bronze Star Medal, died during a Special Forces training exercise in December of 2012. ...
(Date:7/1/2015)... ... July 01, 2015 , ... RowdMap Inc. is a ... white paper: “Pro-actively Identifying the High-Cost Patient Population: Insights from the Health Care ... at: http://www.hcttf.org/resouces-tools . , The Healthcare Transformation Task Force is a group ...
(Date:7/1/2015)... ... 01, 2015 , ... A Priority Setting Partnership put in ... list they hope will guide future mesothelioma research. Surviving Mesothelioma has just posted ... , More than 450 mesothelioma patients, caregivers, and healthcare professionals answer the ...
(Date:7/1/2015)... (PRWEB) , ... July 01, 2015 , ... ... exclusively to healthcare providers, has been retained to lead a national chief ... the top executive search firms in the healthcare industry, B. E. Smith has ...
Breaking Medicine News(10 mins):Health News:OncLive® Welcomes Sarah Cannon Cancer Network to Its Strategic Alliance Partnership Program 2Health News:OncLive® Welcomes Sarah Cannon Cancer Network to Its Strategic Alliance Partnership Program 3Health News:Wife of Fallen Special Forces Soldier to Host Nationwide ‘Virtual 5K’ for Charity 2Health News:Wife of Fallen Special Forces Soldier to Host Nationwide ‘Virtual 5K’ for Charity 3Health News:A Population Based Approach to Pay for Value: RowdMap, Inc. Contributes to Health Care Transformation Task Force White Paper 2Health News:A Population Based Approach to Pay for Value: RowdMap, Inc. Contributes to Health Care Transformation Task Force White Paper 3Health News:New Report Identifies Top 10 Mesothelioma Research Priorities, According to Surviving Mesothelioma 2Health News:Citizens Medical Center Retains B. E. Smith to Recruit New CEO 2Health News:Citizens Medical Center Retains B. E. Smith to Recruit New CEO 3
... no reduced death risk in patients with localized disease, ... -- Oral sodium clodronate improves overall survival in advanced ... death in those with localized disease, British researchers say. ... more than 800 men enrolled in two trials launched ...
... , KENILWORTH, N.J., Aug. 11 Schering-Plough Corporation ... an antihistamine eye drop strong enough to control itchy eyes all day ... are sold, CLARITIN Eye works in minutes to relieve the itch of ... , To view the Multimedia News Release, go to: ...
... , WASHINGTON, Aug. 11 To gain an insider,s ... publisher of the Guide to Retirement Living SourceBook, will ... downtown Washington, D.C. retirement community. Gurney is documenting his experiences and ... the last 20 years, Gurney has immersed himself in the business ...
... , MOUNTAIN LAKES, N.J., Aug. 11 Today ... -- announces the "3 in 4 Need More" campaign to promote ... big hole in it," says Jonas Roeser, a founding member, "if it ... *(PHOTO 72dpi: Send2Press.com/mediaboom/09-0811-LTCG3in4_72dpi.jpg) , , *(Photo Caption/Cutline: ...
... CARY, N.C., Aug. 11 Cornerstone Therapeutics Inc. (Nasdaq: ... products primarily for the respiratory and related markets, today reported financial results for ... Recent Highlights: , , , ... or 78%, compared to 2008 , , ...
... , HERMOSA BEACH, Calif., Aug. 11 On ... committed to improving the quality of life for Latino children with cancer and ... the 2009 AVP CROCS SLAM BUD LIGHT ... (Photo: http://www.newscom.com/cgi-bin/prnh/20090811/LA59829 ) , , In 2009, AVP named ...
Cached Medicine News:Health News:Oral Drug Ups Survival in Advanced Prostate Cancer Cases 2Health News:Photos: New CLARITIN(R) Eye Relieves Itchy Eyes For Up To 12 Hours 2Health News:Photos: New CLARITIN(R) Eye Relieves Itchy Eyes For Up To 12 Hours 3Health News:Middle-Aged Senior Care Advocate to Move Into D.C. Retirement Community 2Health News:New Health Reform Campaign Will Support Long-Term Care for All, Because '3 in 4 Need More' 2Health News:New Health Reform Campaign Will Support Long-Term Care for All, Because '3 in 4 Need More' 3Health News:Cornerstone Therapeutics Reports Second Quarter and First Half 2009 Financial Results 2Health News:Cornerstone Therapeutics Reports Second Quarter and First Half 2009 Financial Results 3Health News:Cornerstone Therapeutics Reports Second Quarter and First Half 2009 Financial Results 4Health News:Cornerstone Therapeutics Reports Second Quarter and First Half 2009 Financial Results 5Health News:Cornerstone Therapeutics Reports Second Quarter and First Half 2009 Financial Results 6Health News:Cornerstone Therapeutics Reports Second Quarter and First Half 2009 Financial Results 7Health News:Cornerstone Therapeutics Reports Second Quarter and First Half 2009 Financial Results 8Health News:Cornerstone Therapeutics Reports Second Quarter and First Half 2009 Financial Results 9Health News:Cornerstone Therapeutics Reports Second Quarter and First Half 2009 Financial Results 10Health News:Cornerstone Therapeutics Reports Second Quarter and First Half 2009 Financial Results 11Health News:Cornerstone Therapeutics Reports Second Quarter and First Half 2009 Financial Results 12Health News:Cornerstone Therapeutics Reports Second Quarter and First Half 2009 Financial Results 13Health News:Cornerstone Therapeutics Reports Second Quarter and First Half 2009 Financial Results 14Health News:Kevin Nealon, Jordan Farmar, Walter Perez, Cristian de la Fuente and Other Celebrities Participated in Beach Volleyball Match for Children With Cancer 2Health News:Kevin Nealon, Jordan Farmar, Walter Perez, Cristian de la Fuente and Other Celebrities Participated in Beach Volleyball Match for Children With Cancer 3
Inquire...
Inquire...
... anti-reflux valve is enclosed in ... prevents the valve from being ... sitting or reclining positions. The ... interference free ensuring uninterrupted flow ...
... valve is enclosed in a ... the valve from being accidentally ... or reclining positions. The valve ... free ensuring uninterrupted flow and ...
Medicine Products: