Navigation Links
MiMedx Reports On Meeting With FDA
Date:10/28/2013

MARIETTA, Ga., Oct. 28, 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, announced today that the Company concluded a productive meeting with the Food and Drug Administration ("FDA") earlier today, October 28, 2013.

Parker H. Petit, Chairman and CEO, said, "We were pleased to have had the opportunity to present to the FDA our basis for concluding that our micronized products are minimally manipulated and meet the criteria for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271 of the FDA's regulations. The FDA acknowledged that our presentation included new information that they would review and consider, and they committed to responding in a timely fashion.  We hope that, upon further analysis, the FDA will agree with our position.  In all events, we are committed to continuing to work with the Agency to agree on a regulatory solution to ensure that our micronized products are available for patients who can benefit from their clinical effectiveness. These solutions could include, among other things, one or more of the following: labeling changes, changes to the product, changes to the process, or submission of a Biologics License Application." 

About MiMedx 
MiMedx® is an integrated developer, manufacturer and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies include AmnioFix® and EpiFix®, our tissue technologies pr
'/>"/>

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

Page: 1 2 3

Related biology technology :

1. MiMedx Group, Inc. to Present at the 6th Annual Canaccord Genuity Cardiovascular, Aesthetics and Metabolic Disorders Conference
2. MiMedx Group Completes $5,000,000 Private Placement
3. MiMedx Group, Inc. Receives CE Certification for Its CollaFix™ Surgical Mesh CD
4. MiMedx to Present at American Academy of Orthopaedic Surgeons Annual Meeting
5. MiMedx Group Announces 2011 Results
6. MiMedx Signs Agreement with Systagenix for Global Distribution of EpiFix®
7. MiMedx Exceeds Revenue Goal for First Quarter of 2012
8. MiMedx Group Announces Record First Quarter Results
9. MiMedx Group, Inc. Announces Release Date for 2012 Second Quarter Results
10. MiMedx Group Announces Record Second Quarter Results
11. MiMedx Group to Present at the Canaccord Genuity Annual Growth Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2014)... 20, 2014 /PRNewswire-iReach/ -- A case study from ... the school,s bioengineering department and the Intel® Internet ... Software Academic Program, UCSD,s research focuses on exploring ... body.  Photo - http://photos.prnewswire.com/prnh/20140819/137540 ... work of Dr. Todd P. Coleman , ...
(Date:8/19/2014)... One of the major limitations ... inadequate vascular supply. Nutrient and gas transport throughout ... critical for successful regeneration and integration into the ... in vascularization and promote angiogenesis in a variety ... design and architecture, and enhancing scaffolds with stem ...
(Date:8/19/2014)... IRVINE, Calif. (PRWEB) August 19, 2014 ... Indiegogo campaign to raise $200,000 to fund a ... diagnostic device. , This development is a ... one-size-fits-all model of care to the implementation of ... patient-centric method of practicing medicine. , Indiegogo contributions ...
(Date:8/19/2014)... 19, 2014 Research and ... the "Spectroscopy Equipment and Accessories - ... their offering. This report ... and Accessories in US$ Thousands by the ... Raman Spectrometers, NMR-EPR Spectrometers, Near Infrared (NIR) ...
Breaking Biology Technology:Intel and University of San Diego Bioengineering Department Release Case Study on Health Sciences Research 2Vascularization in Tissue Engineering Highlighted at 12th New Jersey Symposium on Biomaterials Science 2Cellgen Diagnostics Launches Indiegogo Crowdfunding Campaign for DNA Medical Testing Device 2Cellgen Diagnostics Launches Indiegogo Crowdfunding Campaign for DNA Medical Testing Device 3Global Spectroscopy Equipment and Accessories - Strategic Business Report 2014 2
... InterWest Partners,announced today the appointment of ... firm,s Advisory Committee: Caltech,president Dr. Jean-Lou Chameau, ... commissioner Dr. Mark McClellan. The three will ... strategic guidance,to the firm and its portfolio ...
... S. Young awarded "Most Innovative" award by the Association of ... ... Research Inc. (TSX:,ARI), a biotechnology company discovering and developing the ... Young, President,and Chief Executive Officer, received the "Most Innovative" award ...
... to dramatically reduce their dose of these often harsh ... Medicine in St. Louis have taken a step closer ... drug directly on tumors in rabbits using drug-coated nanoparticles. ... than used previously for this purpose markedly slowed tumor ...
Cached Biology Technology:Prestigious Scientific Leaders Join InterWest Advisory Committee 2Prestigious Scientific Leaders Join InterWest Advisory Committee 3Prestigious Scientific Leaders Join InterWest Advisory Committee 4ARIUS recognized for entrepreneurial excellence 2Nanosized technology has supersized effect on tumors 2Nanosized technology has supersized effect on tumors 3
(Date:8/20/2014)... During the past few years, Virginia Tech,s Wu Feng ... Microsoft grant from the "Computing in the Cloud" program, ... a $6 million award from the Air Force on ... from NSF and the National Institutes of Health on ... wove together the "parallel computing" aspects from each grant, ...
(Date:8/20/2014)... of honeybees grows to about 4,000 members, it triggers ... building of a special type of comb used for ... from the Department of Neurobiology and Behaviour at Cornell ... reproductive cycle of honeybee colonies. The results are published ... Nature . , Reproduction isn,t always a honeybee ...
(Date:8/20/2014)... 2014  The second annual Biometrics UnPlugged Executive ... Tampa, Florida on September 15, 2014, ... Technology and Strategy at Samsung, and Philippe de ... of this year,s event is Mobility at the ... "Biometrics UnPlugged: Mobility at the Crossroads of Commerce ...
Breaking Biology News(10 mins):The internet was delivered to the masses; parallel computing is not far behind 2The internet was delivered to the masses; parallel computing is not far behind 3The internet was delivered to the masses; parallel computing is not far behind 4Worker bees 'know' when to invest in their reproductive future 2Biometrics UnPlugged: Mobility at the Crossroads of Commerce & Privacy to Feature Interactive Sessions with Samsung and Experian 2
... an inherited structural mechanism that can make drugs ... mechanism decreases a protein and in turn causes ... therapies are used to treat patients with childhood ... researchers say their finding advances the field of ...
... may account for many cases of immune deficiency, in ... and Common Variable Immunodeficiency (CVID), report researchers in the ... to a new diagnostic test for these conditions, which ... unrecognized because of a lack of good tests. , ...
... Broken sewers, flooded industrial plants and dead bodies are all likely ... , But the water - and the muck it is leaving ... as it is unexpected: Toxins common in most urban environments that ... atop the city. , So says a University of Florida professor ...
Cached Biology News:Genomics researchers discover protein deficit that causes drug toxicity 2Protein amplification in melanoma is possible drug target 2Toxic flood lifts lid on common urban pollution problem 2Toxic flood lifts lid on common urban pollution problem 3
Anti-ACTH Immunogen: Porcine ACTH conjugated to BSA. Available Date: 38566...
Goat polyclonal to BACE1 ( Abpromise for all tested applications). entrezGeneID: 23621 SwissProtID: P56817...
... Immunogen: ... region encompassing the human, mouse, ... Accession Number: ... Assurance: Routinely evaluated by ...
Mouse monoclonal [MN-8C4] to zona radiata ( Abpromise for all tested applications). Antigen: Purified eggshell proteins (zona radiata proteins and small amounts of zona pellucida proteins) from ...
Biology Products: