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 by increasing demands on the FDA, according to the Tufts Center for the Study of Drug Development (TCSDD). The TCSDD warns that drug approval times may lengthen as pharmaceutical companies compete for attention from the FDA. Furthermore, there are growing demands on the FDA for faster review of drug applications, greater overview of postapproved safety data and closer scrutiny of the ethical conduct of clinical trials. TCSDD director Kenneth Kaitin says that, along with the task of meeting these demands, FDA commissioner Mark McClellan will have to attend to the threat of bioterrorism as well as the proposed transfer of biotechnology product reviews from the Center for Biologics Evaluation and Review to the Center 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 1 Inpharma 25 Jan 2003 No. 1371 1173-8324/10/1371-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Page 1: 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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