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:5/21/2015)... 21, 2015 /PRNewswire/ - SQI Diagnostics Inc. ("SQI" or ... that develops and commercializes proprietary technologies and products for ... results for the second fiscal quarter ended March 31, ... continued to advance business with our existing customers and ... President and CEO of SQI. "The delivery of a ...
(Date:5/21/2015)... (PRWEB) May 21, 2015 uBiome, ... announced a partnership with PicnicHealth, a healthcare company ... Participants diagnosed with Inflammatory Bowel Disease (IBD) will ... a complementary uBiome research kit. Both companies were ... , For more information on this ...
(Date:5/21/2015)... LOS ANGELES , May 21, 2015 /PRNewswire/ ... research and development company specializing in oncology, today ... 2 clinical trial with aldoxorubicin for the treatment ... of brain cancer.  The open-label, multisite trial is ... of aldoxorubicin in patients whose tumors have progressed ...
(Date:5/21/2015)... 21, 2015 Tunnell Consulting, ... firm as senior statistician and Principal, a position to ... in the management and analysis of complex and large ... industries. , “We’re delighted to have Julia join the ... analytics,” said Dr. Philippe Cini, Group Vice President and ...
Breaking Biology Technology:SQI Diagnostics Reports Second Quarter Financial Results 2SQI Diagnostics Reports Second Quarter Financial Results 3SQI Diagnostics Reports Second Quarter Financial Results 4SQI Diagnostics Reports Second Quarter Financial Results 5SQI Diagnostics Reports Second Quarter Financial Results 6SQI Diagnostics Reports Second Quarter Financial Results 7SQI Diagnostics Reports Second Quarter Financial Results 8uBiome Partners with PicnicHealth 2uBiome Partners with PicnicHealth 3CytRx Reports Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer) 2CytRx Reports Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer) 3CytRx Reports Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer) 4CytRx Reports Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer) 5CytRx Reports Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer) 6CytRx Reports Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer) 7Julia O’Neill Joins Tunnell Consulting’s Operational and Process Improvement Practice 2
... - Conference Call Today at 5:00 p.m. Eastern Time ... Poniard,Pharmaceuticals, Inc. (Nasdaq: PARD ), a biopharmaceutical company ... financial results,for the first quarter ended March 31, 2008., ... in moving our,clinical trials forward and generating data to ...
... of 2007 -, - Tests Delivered Grew 68 Percent Compared ... - Conference Call Today ... Genomic Health,Inc. (Nasdaq: GHDX ) today reported financial results and business ... $23.4 million in the first quarter of 2008,compared to $14.1 million in ...
... Revell, world-renowned Pfizer Enterprise 2.0 expert, to deliver ... ... HERSHEY, Pa., May 6 Simon Revell, Manager of ... discuss how Web 2.0,social software can be leveraged to stimulate ...
Cached Biology Technology:Poniard Pharmaceuticals Reports First Quarter 2008 Financial Results and Corporate Update 2Poniard Pharmaceuticals Reports First Quarter 2008 Financial Results and Corporate Update 3Poniard Pharmaceuticals Reports First Quarter 2008 Financial Results and Corporate Update 4Poniard Pharmaceuticals Reports First Quarter 2008 Financial Results and Corporate Update 5Poniard Pharmaceuticals Reports First Quarter 2008 Financial Results and Corporate Update 6Poniard Pharmaceuticals Reports First Quarter 2008 Financial Results and Corporate Update 7Poniard Pharmaceuticals Reports First Quarter 2008 Financial Results and Corporate Update 8Poniard Pharmaceuticals Reports First Quarter 2008 Financial Results and Corporate Update 9Genomic Health Announces First Quarter 2008 Financial Results and Business Progress 2Genomic Health Announces First Quarter 2008 Financial Results and Business Progress 3Genomic Health Announces First Quarter 2008 Financial Results and Business Progress 4Genomic Health Announces First Quarter 2008 Financial Results and Business Progress 5Genomic Health Announces First Quarter 2008 Financial Results and Business Progress 6Genomic Health Announces First Quarter 2008 Financial Results and Business Progress 7Genomic Health Announces First Quarter 2008 Financial Results and Business Progress 8Genomic Health Announces First Quarter 2008 Financial Results and Business Progress 9Hershey Center for Applied Research Supports Acceleration of Scientific Research and Development 2Hershey Center for Applied Research Supports Acceleration of Scientific Research and Development 3
(Date:4/20/2015)... April 20, 2015 Huntington Memorial Hospital is ... implant a new miniaturized, wireless monitoring sensor to manage ... first and only FDA-approved heart failure monitoring device that ... used by physicians to manage heart failure. ... implanted in the pulmonary artery (PA) during a non-surgical ...
(Date:4/14/2015)... 2015 NXT-ID, Inc. (NASDAQ: NXTD ) ... on the growing mobile commerce market, announces that its ... New York Design Awards under the category  ,Product Design ... Design Awards are part of a global multi-disciplinary awards ... from the marketplace, industry and judging panel. Winners will ...
(Date:4/9/2015)... 9, 2015 Synaptics Inc. (NASDAQ: SYNA ), ... that it will report financial results for the third ... after the close of market. The company will host ... 2:00 p.m. PT (5:00 p.m. ET), during which management ... on the live call, analysts and investors should dial ...
Breaking Biology News(10 mins):Huntington Memorial Hospital Becomes First in the San Gabriel Valley to Offer Patients a New Heart Failure Monitoring Solution 2Huntington Memorial Hospital Becomes First in the San Gabriel Valley to Offer Patients a New Heart Failure Monitoring Solution 3NXT-ID's Wocket Smart Wallet Nominated for 2015 New York Design Awards in 'Product Design- Technology' 2NXT-ID's Wocket Smart Wallet Nominated for 2015 New York Design Awards in 'Product Design- Technology' 3Synaptics to Report Third Quarter Results on April 23 2
... mind, it takes some fluorescent protein and a tiny microscope ... a technique for observing hundreds of neurons firing in the ... linked that activity to long-term information storage. The unprecedented work ... neurodegenerative diseases such as Alzheimer,s. The researchers first used ...
... Lab will host its sixth Geothermal Energy Utilization Conference ... Jon Wellinghoff, chairman of the Federal Energy Regulatory Commission, ... manager of the U.S. Department of Energy Geothermal Technologies ... The conference will advance the understanding of ...
... and frogs are about to take up residence in the ... and scientists want to learn more about the water-running lizard,s ... that means how it increases its locomotion efficiency by producing ... its recovery stroke. And these engineers are surprised at ...
Cached Biology News:Stanford researchers develop tool for reading the minds of mice 2SMU conference aims to spur development of geothermal production in oil and gas fields 2SMU conference aims to spur development of geothermal production in oil and gas fields 3Nature's phenomena might teach Virginia Tech engineers new tricks 2Nature's phenomena might teach Virginia Tech engineers new tricks 3
The Discovery Series PDQuest 2-D analysis software is used for imaging, analyzing, and databasing two-dimensional electrophoretic gels. The 10-user network license entitles ten users to access data f...
Mouse monoclonal antibody raised against a partial recombinant NEK2. NCBI Entrez Gene ID = NEK2...
... DS-L2 imaging controller is a successor of ... allows users to comfortably observe, record and ... features an 8.4 inch LCD (XGA) monitor ... Nikon cameras including the DS-Fi1 , DS-5Mc ...
... system for detection of very low level ... Equipped with an extreme sensitive camera to ... plants in tumor research, infectious disease research, ... NightOWL is the only imager with a ...
Biology Products: