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:10/30/2014)... BOSTON, MA (PRWEB) October 30, 2014 ... communication and collaboration provider, offers Office 365 end ... software into a complete phone system by adding ... Office 365 (O365) includes Lync Online, a communication ... to Lync calls. With hosted voice, O365 becomes ...
(Date:10/30/2014)... October 30, 2014 Spartan Bioscience announced ... RX CYP2C19 System . It detects CYP2C19 genetic mutations ... swab. , The Spartan RX CYP2C19 System is the ... been approved in Canada. Due to the system’s ease ... be used by healthcare professionals such as doctors, nurses, ...
(Date:10/30/2014)... Al Khaimah, UAE (PRWEB) October 30, 2014 ... appointment of Dr. James A. Manganello, Chairman of the Board, ... of The Bahamas. The appointment was made by the ... Bahamas on September 24th, 2014. , More than ... Therapy and Research Bill , Prime Minister Perry Christie said ...
(Date:10/30/2014)... N.J. , Oct. 30, 2014  Regado Biosciences, ... it will hold a conference call and live audio ... EST to discuss its third quarter 2014 financial results. ... conference call by dialing (888) 347-1165 for domestic callers ... will be webcast live under the investor relations section ...
Breaking Biology Technology:SoundConnect Launches Voice Enablement and Hybrid Audio Conferencing for Office 365 2SoundConnect Launches Voice Enablement and Hybrid Audio Conferencing for Office 365 3Health Canada approves first near-patient DNA test for personalized medicine 2Health Canada approves first near-patient DNA test for personalized medicine 3Grace Century’s Stem Cell Biobank Project Announces Chairman’s Appointment to National Stem Cell Ethics Committee of The Bahamas 2Grace Century’s Stem Cell Biobank Project Announces Chairman’s Appointment to National Stem Cell Ethics Committee of The Bahamas 3Regado Biosciences to Provide Third Quarter 2014 Financial Results 2
... NBIX ) today announced its financial results for the ... the fourth quarter of 2010, the Company reported net income of ... loss of $7.9 million, or $0.20 per basic share, for the ... the Company reported a net loss of $8.0 million, or $0.15 ...
... Technologies, Inc., a privately-held orthobiologics company, announced today that ... is scheduled to present at Canaccord Genuity,s Musculoskeletal Conference ... February 15, 2011 at 10:00 AM (PT).  The conference, ... Meeting, will feature presentations from over 60 public and ...
... Mass., Feb. 10, 2011 Qteros, Inc., ... Bioprocessing (CBP) platform for the lowest-cost production ... engagements across the United States and Europe for members ... Qteros, Senior Vice President, Commercial Development and Engineering, will ...
Cached Biology Technology:Neurocrine Biosciences Reports Fourth Quarter and Year End 2010 Results 2Neurocrine Biosciences Reports Fourth Quarter and Year End 2010 Results 3Neurocrine Biosciences Reports Fourth Quarter and Year End 2010 Results 4Neurocrine Biosciences Reports Fourth Quarter and Year End 2010 Results 5Neurocrine Biosciences Reports Fourth Quarter and Year End 2010 Results 6Neurocrine Biosciences Reports Fourth Quarter and Year End 2010 Results 7ISTO Technologies, Inc. to Present at Canaccord Genuity's Musculoskeletal Conference 2Qteros Management to Present at Notable Alternative Energy Conferences in February 2
(Date:10/29/2014)... At a ceremony held in New York City on ... King, the American Cancer Society Professor of Genome Sciences ... and 2008 Honorary Doctor of Philosophy of Tel Aviv ... in Medical Science. , In addition to her honorary ... Lecturer at the TAU School of Medicine, and for ...
(Date:10/29/2014)... Hebei, China — BGI Tech and Hebei Agricultural University ... Jujube genome. Jujube is the most economically important member ... particularly difficult to sequence due the high level of ... time that a genome in the Rhamnaceae (Buckthorn) family ... in Nature Communications . , Jujube ...
(Date:10/28/2014)... the tragic realities of cancer is that the ... and their effectiveness varies unpredictably from patient to ... to change this reality by rapidly assessing how ... individual,s cancer before chemotherapy begins. , A team ... Assistant Professor Melissa Skala has developed the technique, ...
Breaking Biology News(10 mins):Geneticist and humanitarian: Prof. Mary-Claire King receives Lasker Award 2BGI Tech and Hebei Agricultural University complete the genome sequencing of the jujube tree 2Improving breast cancer chemo by testing patient's tumors in a dish 2Improving breast cancer chemo by testing patient's tumors in a dish 3
... A new computer model of the Gulf of Mexico ... how underwater currents may have primed marine microorganisms to degrade ... of water move over the ruptured well, picking up hydrocarbons. ... over the well, the bacteria have already been activated, are ...
... Species pairs that disappear through hybridization after ... the disturbance is removed, according to a new ... reemergence might happen. The findings, published in ... conservationists and ecosystem managers interested in preserving, or ...
... Foundation for Biodiversity, the Charter Provincial Council of Gipuzkoa and ... be studying the re-stocking of the three eel phases (elver, ... and July, respectively, in three streams of the Oria basin. ... be able to manage the species and thus contribute to ...
Cached Biology News:Gulf currents primed bacteria to degrade oil spill 2Species reemergence after collapse: Possible but different 2A study will enable the survival and growth of the 3 development phases of the European eel 2
... The ProteoExtract™ Protein Precipitation Kit ... up of proteins from aqueous samples. ... by the presence of non-protein impurities ... in the protein sample that interfere ...
... activated carrier proteins to simplify the ... Activated Carrier Proteins are commonly used ... a heterobifunctional cross-linker (Sulfo-SMCC). This activation ... protein. Thus allowing the maleimide-activated ...
... This kit allows for rapid, convenient, ... The simple bind/wash/elute process utilizes a spin ... uses beads for concentration of proteins which ... beads are strong ion exchangers, offering high ...
... optically clear polystyrene with frosted labeling ... for cell counting. 100% integrity tested. ... new product number, created to easily ... no availability yet, please order under ...
Biology Products: