Manufacturing-Contract
FDA is rejecting more new drugs than in past
Agency is 'more cautious' in wake of Vioxx problems, expert says
Date:
08/17/2007
, Publication:
MSNBC
, Author:
Associated Press
http://www.msnbc.msn.com/id/20321830/
AIDS drugs sales could top $10 billion by 2015
New treatments, increasing number of people with HIV behind growth
Date:
04/12/2007
, Publication:
MSNBC
, Author:
Reuters
http://www.msnbc.msn.com/id/18074155/
Get a Grip on the Supply Chain
Sarbanes-Oxley revenue-recognition compliance is reducing perfectly competent execs to complete blubber. Here's help in figuring out when a sale is really a sale.
Date:
04/01/2007
, Publication:
Pharmaceutical Executive
, Author:
Lisa Papwoth, Tim Kelly, Stuart Kamin
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=418779
Justifying the Means
Much can be said for the ethics of innovation.
Date:
02/01/2007
, Publication:
Pharmaceutical Technology
, Author:
Kaylynn Chiarello-Ebner
http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=400641
Innovations in API Synthesis
As custom manufacturers gather for InformexUSA this month, strategies in asymmetric synthesis and catalysis prevail.
Date:
02/01/2007
, Publication:
Pharmaceutical Technology
, Author:
Patricia Van Arnum
http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=400918
Industry, Regulators Move to Adopt Quality Standards
Harmonization spurs efforts to implement modern manufacturing systems and risk-management programs.
Date:
02/01/2007
, Publication:
Pharmaceutical Technology
, Author:
Jill Wechsler
http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=400644
India: Give or Take?
Responsibility is key to giving back to the research-rich country.
Date:
02/01/2007
, Publication:
Applied Clinical Trials
, Author:
Nigel Page
http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=4
FDA Issues Final Manufacturing Quality Systems Guidance for Pharmaceutical Industry
New Recommendations Facilitate Modernization of Drug Manufacturing
Date:
09/29/2006
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01471.html
FDA Issues Guidance to Industry for Development of Cell-Based Viral Vaccines
Technology for New-Generation Vaccines for Viral Infectious Diseases
Date:
09/28/2006
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01470.html
FDA Fines American Red Cross $4.2 Million for Failure to Meet Established Blood Safety Laws
The violations include breaches of Good Manufacturing Practice (GMP) such as a failure to ask appropriate...
Date:
09/08/2006
, Publication:
FDA News
, Author:
FDA
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01447.html
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