Strategy-Launch and Pre-Launch Clinical Trials
Two Widely Used Infertility Treatments Fail in Study
For couples with unexplained infertility, artificial insemination and a drug stimulating ovulation are no better than simple counseling, scientists said.
Date:
08/10/2008
, Publication:
NY TIMES
, Author:
ASSOCIATED PRESS
http://www.nytimes.com/aponline/health/AP-MED-Fertility-Methods.html?ref=health
FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
The improvements include stricter limits on financial conflicts of interest for committee members, ...
Date:
08/05/2008
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01871.html
Drug Test a Success for Amgen
The biotechnology company reported a successful trial for an experimental osteoporosis drug that reduced the risk of bone fractures in post-menopausal women.
Date:
07/26/2008
, Publication:
NY TIMES
, Author:
ANDREW POLLACK
http://www.nytimes.com/2008/07/26/business/26amgen.html?ref=health
Family Sues Company for Experimental Muscular Dystrophy Drug
A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it.
Date:
07/19/2008
, Publication:
Fox News
, Author:
AP
http://www.foxnews.com/story/0,2933,385548,00.html
FDA Rule and Companion Guidance Make Early Stage Clinical Drug Development Safe and EfficientDate:
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
VIDEO-Do you want to be a guinea pig?
Clinical trials aggressively recruiting test subjects with billboards, posters
Date:
06/29/2008
, Publication:
CNN
, Author:
Elizabeth Cohen
http://www.cnn.com/2008/HEALTH/06/26/ep.clinical.trials/index.html#cnnSTCVideo
Researchers Fail to Reveal Full Drug Pay
...earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials...
Date:
06/09/2008
, Publication:
NY TIMES
, Author:
GARDINER HARRIS and BENEDICT CAREY
http://www.nytimes.com/2008/06/08/us/08conflict.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
Coronary Artery Plaque Imaging Device Cleared by FDA
The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.
Date:
04/29/2008
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01827.html
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