FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
CDER Home About CDER Drug Information Regulatory Guidance CDER Calendar Specific Audiences CDER Archives
 
Powered by Google
 

Drug Safety Oversight Board Meeting
September 18, 2008, Public Summary

  • The Executive Director updated the Board on Public Health Advisories (PHAs) and Information for Healthcare Professionals (HCP) sheets posted since the July 17, 2008 meeting (available at http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm) and those currently in development.


  • The Board discussed recent data about the potential for cardiovascular risks with the use of stimulant drugs in children with attention deficit/hyperactivity disorders (ADHD), and the recent statements by the American Heart Association, the American Academy of Pediatrics and other medical organizations regarding the advisability of heart monitoring for children receiving stimulant drugs.


  • The Board was updated on a topical tretinoin skin cancer prevention trial that was first discussed at the March 20, 2008, Drug Safety Board Meeting and the plans for the Department of Veterans Affairs to publish the results of this trial.


  • The Board had a general discussion with the CDER Center Director about its ongoing role in risk communication and safety policy.


 

to top arrow Back to Top     back arrow DSOB Meeting Summaries

PDF document PDF requires the free Adobe Acrobat Reader

Date created: October 3, 2008

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA/Center for Drug Evaluation and Research