Advertisement
 

doctorslounge.com

 
Powered by
Careerbuilder

 

                    Home  |  Forums  |  Humor  |  Advertising  |  Contact
   Ask a Doctor

   News via RSS

   Newsletter

   Pharmacy

   News

 

 Conferences


   CME

   Forum Archives

   Diseases

   Symptoms

   Labs

   Procedures

   Drugs

   Links
   Specialties

   Cardiology

   Dermatology

   Endocrinology

   Fertility

   Gastroenterology

   Gynecology

   Hematology

   Infections

   Nephrology

   Neurology

   Oncology

   Orthopedics

   Pediatrics

   Pharmacy

   Primary Care

   Psychiatry

   Pulmonology

   Rheumatology

   Surgery

   Urology

   Other Sections

   Membership

   Research Tools

   Medical Tutorials

   Medical Software

pharmacorner.gif (8x8 -- 103 bytes)
 

 Headlines:

 
 

Back to Pharmacology Articles

Friday, 5th November 2004

The FDA was widely criticized for apparent shortcomings of its internal appeals process for scientists that wish to challenge regulatory decisions.

 

tellfrnd.gif (30x26 -- 1330 bytes)send to a friend
 
prntfrnd.gif (30x26 -- 1309 bytes)printer friendly version
 
  Related
 
Antidepressants may be linked to suicidal behavior (FDA warning)
Bextra, Vioxx, Celebrex and heart disease

In the wake of recent high-profile safety concerns about widely used drugs, including antidepressants (related article) and Vioxx (related article), Dr. Lester M. Crawford, Acting FDA Commissioner, today announced that they will launch a review of the agency's drug monitoring policies.

The FDA was widely criticized for apparent shortcomings of its internal appeals process for scientists that wish to challenge regulatory decisions. In the case of Vioxx, FDA scientist David Graham reportedly complained to lawmakers that he was intimidated when he attempted to have the agency disclose his research suggesting the drug was potentially unsafe. In the antidepressants case, Andrew D. Musholder, MD, complained he was barred from informing an advisory panel about safety concerns with antidepressants because of suicide risk.

The new procedure will allow FDA's Center for Drug Evaluation and Research (CDER)  to formally address concerns over safety decisions to a three-member panel that includes outside experts. The panel would then have 30 days to review all relevant materials and recommend to the Center Director an appropriate course of action.

The CDER will also conduct a national search to fill the currently vacant position of Director of the Office of Drug Safety, which is responsible for overseeing the post-marketing safety program for all drugs.

By the end of this year, FDA intends to publish final versions of three guidances that have been developed by our agency to help pharmaceutical firms manage risks involving drugs and biological products. These guidances should assist pharmaceutical firms in identifying and assessing potential safety risks before a drug reaches the market and also after a drug is already on the market using good pharmacovigilance practices and pharmacoepidemiologic assessment.

Source: Food and Drug Administration

advertisement.gif (61x7 -- 0 bytes)
 

Are you a doctor or a nurse?

Do you want to join the Doctors Lounge online medical community?

Participate in editorial activities (publish, peer review, edit) and give a helping hand to the largest online community of patients.

Click on the link below to see the requirements:

Doctors Lounge Membership Application


Article reviewed by:

Dr. Tamer Fouad, M.D.

 

 advertisement.gif (61x7 -- 0 bytes)

 

 



We subscribe to the HONcode principles of the HON Foundation. Click to verify.
We subscribe to the HONcode principles. Verify here

Privacy Statement | Terms & Conditions | Editorial Board | About us
Copyright 2001-2012 DoctorsLounge. All rights reserved.