BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Mayne Pharma Failed To Report US Drug Reactions


10/19/2005 5:12:41 PM

Pharmaceuticals and diagnostics firm Mayne Group Ltd (ASX:MAY) has received a highly critical warning letter from the US regulatory authority on Mayne's reporting of adverse drug events (ADE) or suspected adverse patient reaction to medicines. But Mayne said today that it had already moved to satisfy the concerns expressed by the US Food and Drug Administration (FDA), which the company said did not relate to the quality of its drugs and would have no material impact on its 2005 financial results. The FDA's letter of February 1, 2005, to the Mayne Pharma business in the US says an audit conducted from September to October 2004 at Mayne's head office in New Jersey revealed that Mayne had violated US regulations on the reporting of and response to ADEs. Those violations included failing to submit ADE reports to the FDA in various cases. The FDA said the company had also submitted reports on some cases after the time required by the FDA, in one case involving morphine, 2,539 days late. Furthermore, Mayne had failed to conduct a follow-up investigation into "all serious and unexpected ADEs". The FDA said, however, that it had received a response letter from Mayne dated November 3, 2004, and had completed a review of Mayne's corrective actions. The FDA said it considered Mayne's proposed corrective actions to be "adequate" even though it still had several questions regarding the company's response.

Read at Sydney Morning Herald
Read at The Age
Read at Asia Pulse

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES