http://www.reg-markets.net/events/page.php?id=140

Shortening Drug Approval Times via Industry Funding of the FDA: Did Legislation Help or Hurt?

Wednesday, February 16, 2005

 

The FDA is charged with assuring the safety and efficacy of new drugs while also making them available to the public as quickly as possible. To help meet these competing pressures, Congress enacted the Prescription Drug User Fee Act (PDUFA) in 1992. This Act imposed performance goals on the FDA and allowed it to levy fees on pharmaceutical firms to provide the resources necessary to meet those goals. Although Congress has renewed PDUFA twice since it originally passed, there is little evidence on its effectiveness. This Joint Center conference will present and critically review some of the first empirical research on the impact of PDUFA on drug approval times.

 

 

FDA Medication Guide for NSAIDs

SJS/TEN and NSAID's

Non-steroidal anti-inflammatory pain drugs, NSAID's, are some of the most prescribed medications, and in general are used to relieve pain and inflammation.  They are also available in many over-the-counter medications containing Ibuprofen such as Advil Cold and Sinus, Advil Cold, Advil Allergy Sinus, Children’s Advil Allergy Sinus, Ibuprofen Cold and Sinus, Sine-Aid IB, and Children's Motrin Cold.

 Based on the citizen repetition submitted in February, 2005, the Food and Drug Administration (FDA) has directed drug manufacturers to make labeling changes to Ibuprofen and other non-steroidal anti-inflammatory drugs that include additional warnings regarding the risks of Stevens - Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN).

We  tirelessly supported the citizen petition filed with the FDA to make the public aware of the possible risks related to these drugs and SJS/TEN.

 In addition to the labeling changes for NSAID's, the FDA has published a user-friendly Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on their website. This FDA document lists life-threatening skin reactions as one of the possible serious side effects of NSAIDs.

 The document is available on the FDA website in HTML and PDF format at:

 http://www.fda.gov/cder/drug/infopage/cox2/NSAIDmedguide.htm

 
 
  

 FDA Safety News Articles

  

http://www.docstoc.com/docs/document-preview.aspx?doc_id=19628605

FDA'S DRUG APPROVAL PROCESS: UP TO THE CHALLENGE? Senate Congressional Report, 109th Congress, 2005-2006 -