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:1/14/2014)... 14, 2014 Date: Friday, April 11, 2014 ... Country Club, 1360 Almshouse Road, Warrington, Pa. , ... solely dedicated to finding a cure for hepatitis B and ... host its annual Crystal Ball on Friday, April 11 at ...
(Date:1/14/2014)... Jan. 14, 2014 As pet owners drew up their lists ... them wrote: "Take better care of my furry companion." Nowadays there ... and top-brand carrying cases to take the little canine or feline ... feel compelled to buy some pricey toys at the pet store. ...
(Date:1/14/2014)... iLab Solutions, the leader in core facility management ... Product Strategy. In this role, Michelle will work with current ... in the development of iLab products. Her main goal will ... to the scientific community by offering the most advanced, user-friendly, ...
(Date:1/14/2014)... ®, provider of RapidResponse ®, a cloud-based supply chain ... S&OP ) service, is proud to be a gold sponsor ... at the Hilton San Diego Bayfront, January 30 – 31, ... , Director of Supply Chain at Amgen, as she presents ...
Breaking Biology Technology:Hepatitis B Foundation to Host Annual Crystal Ball Gala 2New Year's Resolution: Give Pets the Gift of Top-Notch Health Care 2iLab Solutions Announces Michelle Detwiler as the New Director of Product Strategy 2Event Alert: Kinaxis Customer to Present at the Biomanufacturing Summit "Supply Chain: Improving Network Effectiveness" 2
... SAN DIEGO, April 9, 2012 ADVENTRX Pharmaceuticals, Inc. ... establishment of a Regulatory Advisory Board (RAB). The RAB ... Company management in its interactions with the U.S. Food ... JD, who is rendering legal advice to Company management, ...
... wholly owned subsidiary of British company Innovative Carbon Limited today ... 10th April to 13th. , Graphene, a sheet of carbon ... wonder material. First isolated at Manchester University in 2004, ... race has been on to produce it commercially. To ...
... 2012  Albright Stonebridge Group (ASG), a global strategy ... senior advisors – Hakan Akbas, Steven Bipes, Brian ... leading ASG,s commercial activities and advising clients on ... clients of ASG,s Brazil practice as they look ...
Cached Biology Technology:ADVENTRX Announces Establishment of Regulatory Advisory Board 2ADVENTRX Announces Establishment of Regulatory Advisory Board 3ADVENTRX Announces Establishment of Regulatory Advisory Board 4ADVENTRX Announces Establishment of Regulatory Advisory Board 5ADVENTRX Announces Establishment of Regulatory Advisory Board 6UK company to demonstrate their commercially effective graphene production process 2Experts Strengthen Albright Stonebridge Group's Global Reach 2Experts Strengthen Albright Stonebridge Group's Global Reach 3
(Date:4/17/2014)... recent Yokahama IPCC meeting painted a stark warning on ... which has a greenhouse effect 32 times that of ... shown that humic substances act as fully regenerable electron ... are held in wetlands instead of being released to ... system is disrupted it may enter into a vicious ...
(Date:4/17/2014)... the genetic information of DNA is used to ... numerous different functions in living organisms. Messenger RNA ... expression, by relating the genetic information of DNA ... , By examining the different types and ... at a given time, researchers can determine which ...
(Date:4/17/2014)... uncovered a new way the immune system may fight ... to use immune cells to treat illness. , The ... immunological equivalent of "neighborhood police" specialized squads of ... instead of an entire city, the body. , Scientists ... have shown that the liver, skin and uterus each ...
Breaking Biology News(10 mins):Methane climate change risk suggested by proof of redox cycling of humic substances 2Rapid and accurate mRNA detection in plant tissues 2Some immune cells defend only 1 organ 2
... presented the 2013 Gustav O. Lienhard Award to Steven ... have helped save millions from premature, smoking-related deaths. ... as well as his work to improve end-of-life care. ... award to a dedicated champion of health for Americans ...
... -- Carnegie Mellon University President Subra Suresh has been ... making him the only current university president to be ... National Academy is among the highest professional distinctions accorded ... membership honors those who have made outstanding contributions to ...
... WASHINGTON -- The Institute of Medicine of the National Academies ... Clayton for their outstanding service today at the IOM,s 43rd ... Medal, awarded to an IOM member for distinguished service over ... on the Quality of Health Care in America, which produced ...
Cached Biology News:Leader of smoking cessation and tobacco prevention efforts receives Institute of Medicine's 2013 Lienhard Award 2Leader of smoking cessation and tobacco prevention efforts receives Institute of Medicine's 2013 Lienhard Award 3Leader of smoking cessation and tobacco prevention efforts receives Institute of Medicine's 2013 Lienhard Award 4Carnegie Mellon President Subra Suresh elected to Institute of Medicine 2Institute of Medicine honors members for outstanding service 2Institute of Medicine honors members for outstanding service 3
... Development, Pharmaceutical Development, Physician Owned Labs, Drugs of Abuse, and Industrial Testing applications. Analyzer ... ... ... ...
... OS X provides the most highly integrated ... analysis and molecular biology data management available ... Suite you can store manage view analyze ... molecular biology data all within one integrated ...
... determinations for petroleum-based applications. Multiple solvents can be used, such as water, benzene, formamide, nitrobenzene, ... ... ... ...
rat Leptin...
Biology Products: