CRO-CSO, Contract Organizations
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
Holding Pattern
The industry experienced solid growth in 2006, but the real action was among the midsize companies.
Date:
05/01/2007
, Publication:
Pharmaceutical Executive
, Author:
Pharmaceutical Executive
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=423201
Ukraine Emerges as a Viable Location for Global Studies
Trials are on the rise in the country, where recruitment rates are high but custom procedures can pose a problem.
Date:
05/01/2007
, Publication:
Applied Clinical Trials
, Author:
Olena Rudnyeva
http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=4
Investigative Sites Unlock the Door to Success in India
The clinical development sector in India engaged in global clinical trials for product registration with international regulatory bodies is fast approaching an inflection point.
Date:
05/01/2007
, Publication:
Applied Clinical Trials
, Author:
Nermeen Varawalla
http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=4
Kid Tested, Government Approved?
Critics claim pharma is too richly rewarded for studying drugs in children. Now, several proposals are on the table that just might change that.
Date:
05/01/2007
, Publication:
Pharmaceutical Executive
, Author:
Kevin A. Schulman
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=423216
CRO Shifts in the Outsourcing Market
The CRO market is going through major and unanticipated structural changes
Date:
05/01/2007
, Publication:
Applied Clinical Trials
, Author:
Kenneth A. Getz
http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=4
Opinion: Are Price Controls the New Black?
...the legislation might just pass—and spell failure for the future of innovative drug development.
Date:
05/01/2007
, Publication:
Pharmaceutical Executive
, Author:
Peter Pitts
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=423214
Critical Mass for Critical Path?
...the rewards of collaboration now look greater than the risks....
Date:
05/01/2007
, Publication:
Pharmaceutical Executive
, Author:
Dan Weiner, Mark Hovde
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=423202
Opinion: Trigger Points
As pharma begins to confront the looming issue of sales-force downsizing, execs should keep an eye on six factors that can help answer that very question.
Date:
03/01/2007
, Publication:
Pharmaceutical Executive
, Author:
Kim D. Slocum
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=408482
The Best-Sellers List
The 2007 Sales and Marketing Quality Ranking scores the most effective sales forces in the industry.
Date:
03/01/2007
, Publication:
Pharmaceutical Executive
, Author:
Mike Luby, Patrick Howie
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=410701
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