us drug approval may be slowed by increasing demands on fda

Inpharma 1371 - 25 Jan 2003

■ The approval of drugs in the US may be slowed byincreasing demands on the FDA, according to the TuftsCenter for the Study of Drug Development (TCSDD).The TCSDD warns that drug approval times maylengthen as pharmaceutical companies compete forattention from the FDA. Furthermore, there aregrowing demands on the FDA for faster review of drugapplications, greater overview of postapproved safetydata and closer scrutiny of the ethical conduct ofclinical trials. TCSDD director Kenneth Kaitin says that,along with the task of meeting these demands, FDAcommissioner Mark McClellan will have to attend tothe threat of bioterrorism as well as the proposedtransfer of biotechnology product reviews from theCenter for Biologics Evaluation and Review to theCenter for Drugs Evaluation and Review.Rising demands may lengthen approval times. Pharma Times News [online] :[1 page], 14 Jan 2003. Available from: URL: http://www.ptwebcast.com 800925282

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Inpharma 25 Jan 2003 No. 13711173-8324/10/1371-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved