Pharmaceuticals US-FDA

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Little monitoring for 'off-label' drug marketing

Report: FDA doesn't track drug makers peddling meds for unapproved use

Date: 07/27/2008 , Publication: MSNBC , Author: AP

http://www.msnbc.msn.com/id/25874072/

Trial Intensifies Concerns About Safety of Vytorin

In a clinical trial, the cholesterol-lowering drug Vytorin did not help people with heart-valve disease avoid further heart problems but did appear to increase their risk of cancer, scientists reported Monday.

Date: 07/22/2008 , Publication: NY TIMES , Author: ALEX BERENSON

http://www.nytimes.com/2008/07/22/business/22drug.html?ref=health

FDA Rule and Companion Guidance Make Early Stage Clinical Drug Development Safe and Efficient

Date: 07/19/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01863.html

FDA Revises Process for Responding to Drug Applications

The U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

Date: 07/09/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01859.html

Advisory Panel Approves 2 New Combination Vaccines

A federal advisory panel on Thursday endorsed two new combination vaccines designed to reduce the number of needle sticks that young children must endure to get the recommended immunizations.

Date: 06/26/2008 , Publication: NY TIMES , Author: AP

http://www.nytimes.com/aponline/health/AP-MED-Combination-Vaccines.html?ref=hea

FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs

...to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death...

Date: 06/16/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01851.html

F.D.A. to Expand Scrutiny of Risks From Drugs After They're Approved for Sale

The new system, called the Sentinel Initiative, will allow officials from the Food and Drug Administration for the first time to monitor almost immediately how drugs affect health...

Date: 05/23/2008 , Publication: NY TIMES , Author: GARDINER HARRIS

http://www.nytimes.com/2008/05/23/washington/23fda.html?ref=health

Bowel Function: FDA Approves Entereg to Help Restore Bowel Function Following Surgery

...approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery.

Date: 05/21/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01838.html

Manufacturer Removes Remaining Stocks of Trasylol

Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market...

Date: 05/14/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01834.html

FDA to launch pilot on drug names and safety

FDA is holding a meeting, launching a pilot, and releasing a concept paper about drug names next month.

Date: 05/13/2008 , Publication: Drug Topics Daily News , Author: Judy Chi

http://drugtopics.modernmedicine.com/drugtopics/Government+And+Law/FDA-to-launc

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