Navigation Links
ViroPharma Provides Update on Upcoming FDA Advisory Committee Meeting to Discuss Bioequivalence of Locally Acting Gastrointestinal Drugs
Date:7/8/2008

ca (IDSA) expressing concerns of infectious disease experts. A copy of ViroPharma's letter and the attachment is now available on ViroPharma's website at http://www.viropharma.com/OGDpetition/.

FDA has indicated that ViroPharma can expect the opportunity for public input regarding bioequivalence methods for Vancocin, but has not yet committed to a next step. Commented Colin Broom, M.D., ViroPharma's vice president, chief scientific officer, "We are encouraged that FDA appears to be taking the first step toward a public process to consider the development of bioequivalence methods for locally acting drugs that treat gastrointestinal conditions. After the general discussion at the July 23rd Advisory Committee meeting, FDA should be better prepared to conduct a public process on bioequivalence methods for Vancocin specifically. ViroPharma is prepared to participate in that process when the time comes. We have long contended that changes in GI physiology observed in patients with Clostridium difficile infection make healthy gut bioequivalence models inapplicable to drugs, like Vancocin, which treat this condition."

ViroPharma has previously explained in various submissions to FDA that appropriate public process for development of bioequivalence methods specifically for Vancocin should include (1) public proposal of the method and the data FDA believes validate that method; (2) FDA receipt of and response to public comments on the proposed method; (3) consideration by the appropriate FDA Advisory Committees, including the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; and (4) final decision making on whether to adopt the method by neutral scientific and medical experts, not the FDA personnel who originally proposed the method. ViroPharma continues to believe that bioequivalence for Vancocin is deserving of at least the same level of process and scientific discussion
'/>"/>

SOURCE ViroPharma Incorporated
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Viropharma Comments On Upcoming FDA Advisory Committee Meeting
2. ViroPharma to Present at Two Upcoming Healthcare Conferences
3. ViroPharma to Present at the Seventh Annual JMP Securities Research Conference
4. ViroPharma to Present at the Cowen & Company 28th Annual Healthcare Conference
5. ViroPharma to Present at the Susquehanna Financial Group Second Annual Significant Options in Healthcare Conference
6. ViroPharma to Release 2007 Fourth Quarter and Full Year Financial Results on February 27, 2008
7. ViroPharma to Present at the BIO CEO & Investor Conference
8. ViroPharma Provides 2008 Outlook
9. ViroPharma to Present at Two Upcoming Healthcare Conferences
10. Vasogen Provides Corporate Update
11. Culligan's New Aqua-Cleer Advanced Drinking Water SystemProvides Clean, Quality Water Customized for Every Home
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/30/2015)... MINNEAPOLIS, MN , April 30, 2015 /PRNewswire/ - ... company producing sustainable chemicals, today announced that it has commenced ... addition, BioAmber expects to grant the underwriters a 30-day ... of the shares of common stock offered in the ... and there can be no assurance as to whether ...
(Date:4/30/2015)... ALEXANDRIA, Va. , April 30, 2015 ... provides senior debt to life sciences and healthcare services ... senior secured term loan agreement with Celula, Inc., a ... diagnosing major diseases, enabling better patient care and improved ... continue the development and expand the commercialization of its ...
(Date:4/30/2015)... MA & Budapest, Hungary (PRWEB) April 30, 2015 ... only web-based electronic lab notebook with integrated protocols ... in providing chemistry software solutions and consulting services ... led to the development of Labguru’s newest feature: ... set of deep domain features for biologists, bio-chemists, ...
(Date:4/30/2015)... 2015  Pfenex Inc. (NYSE MKT: PFNX) a ... biosimilar therapeutics including high value and difficult to ... previously announced underwritten public offering of 6,750,000 shares ... price of $15.50 per share. This includes the ... option to purchase up to 750,000 additional shares ...
Breaking Biology Technology:BioAmber Inc. Announces Public Offering Of Common Stock 2BioAmber Inc. Announces Public Offering Of Common Stock 3Oxford Finance Provides $10 Million Debt Financing to Celula 2Labguru Integrates ChemAxon's Marvin JS, to Enhance Functionality for Chemists 2Pfenex Inc. Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters' Option to Purchase Additional Shares 2
... 6 NPS,Pharmaceuticals, Inc. (Nasdaq: NPSP ) announced ... any and all of its outstanding 3.0% Convertible,Notes due ... Time on,October 4, 2007, unless extended. The tender offer, ... the related letter of transmittal, is not,subject to the ...
... and ST. LOUIS, Sept. 6 Resource ... (GPO) serving St. Louis-,based Sisters of Mercy ... Elekta,enabling members to begin purchasing Elekta,s innovative ... ) Under the agreement, Mercy will ...
... BARCELONA, Spain, Sept. 6 Elekta, a ... solutions, will showcase,the latest advances in radiotherapy, ... European Society of Therapeutic Radiation,Oncologists (ESTRO) 2007 ... 2,000 physicists, radiotherapists, oncologists and other health ...
Cached Biology Technology:NPS Pharmaceuticals Commences Tender Offer for 3.0% Convertible Notes Due 2008 2NPS Pharmaceuticals Commences Tender Offer for 3.0% Convertible Notes Due 2008 3NPS Pharmaceuticals Commences Tender Offer for 3.0% Convertible Notes Due 2008 4Elekta Contract Provides Sisters of Mercy Health System Access to Leading Radiation Therapy Solutions 2Elekta To Showcase Innovations in Radiotherapy and Unveil New Product That Expands Cancer Treatment Availability 2Elekta To Showcase Innovations in Radiotherapy and Unveil New Product That Expands Cancer Treatment Availability 3
(Date:3/23/2015)... 2015   HOYOS Labs , a leading global ... that the Company will demonstrate multiple biometrics-based technologies under ... at Connect:ID on March 23 through 25, 2015, in ... highlight the IEEE Biometric Open Protocol Standard; free biometrics-based ... access control system. BOPS was invented by HOYOS Labs ...
(Date:3/20/2015)... , Mar. 20, 2015 Research and Markets ... addition of the "India Sensors Market Forecast ... The sensor market is projected to ... Consumer electronics, automotive, industrial and healthcare ... in the country. In addition, adoption of MEMS ...
(Date:3/20/2015)... Markets ( http://www.researchandmarkets.com/research/vkzvcs/iris_biometrics ) has announced the addition ... report to their offering. This report analyzes ... report provides separate comprehensive analytics for the US, ... Europe , Asia-Pacific , ... . Annual estimates and forecasts are provided for ...
Breaking Biology News(10 mins):HOYOS Labs to Showcase Host of Biometrics Technologies at Connect:ID in Washington, D.C. 2HOYOS Labs to Showcase Host of Biometrics Technologies at Connect:ID in Washington, D.C. 3India Sensors Market Forecast and Opportunities 2020 - STMicroelectronics held the largest share in 2014 2India Sensors Market Forecast and Opportunities 2020 - STMicroelectronics held the largest share in 2014 3Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 2Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 3Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 4Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 5
... has been a focal point of recent climate change research ... than the larger Antarctic ice sheet. Yet while the southern ... clear how much this is contributing to rising sea levels, ... research was defined at a recent workshop organised by the ...
... overlooked and undervalued protein, sarcospan, just got its ... show that adding it to muscle cells might ... In Duchenne muscular dystrophy (DMD), the mutated dystrophin ... glycoprotein complex. And without this anchoring, muscle cells ...
... day be mended using a novel scaffold developed by MIT ... heart cells or stem cells seeded onto such a scaffold ... be used to treat congenital heart defects, or aid the ... scaffold would be gradually absorbed into the body, leaving behind ...
Cached Biology News:What is really happening to the Greenland icecap? 2MIT: Mending broken hearts with tissue engineering 2
... CGH Genomic Labeling Systems are a high-performance ... genomic DNA samples for array-based Comparative Genomic ... direct labeling formats, the BioPrime Plus Array ... solution to your genomic labeling needs. ...
We offer solid and solution phase peptide synthesis including a whole range of modifications. Please send the details of your peptide synthesis need to info@rpeptide.com...
... Neural Stem Cell Expansion Kit - Monolayer is ... NSC expansion as a monolayer in a serum-free ... Plus Media Supplement, which has been optimized for ... al . (1996) Genes & Development 10 ...
... DNA Polymerase I from E. ... polymerase. The enzyme also contains ... The 5'?3' exonuclease activity enables ... and gaps in the DNA ...
Biology Products: