The US victuals and Drug Administr...

The US victuals and Drug Administration's (FDA's) Center for medicine Evaluation and Research (CDER) achieved the fastest median approval times in 1997 for medications that are supported by way of user fees, and approved the inferior highest total of important novel products.

The median approval time for last year's 121 of the present day original medications was 14.4 months-- 6% les than the 154 month in 1996 The median CDER review time for these performances was 12.2 months-- 18% les than the year before. Thirty-nine of the recently made known original medications were new molecular entities (NMEs) which contain an active substance that had none been approved for marketing in the United States.

Nine of the NME were priority medications that received an accelerated review because they exhibit a major advance in medical treatment. These medications included

* Viracept--a of the present day protease inhibitor for treatment of HIV infection, approved in 26 months;

* Evista--a medication indicated to debar osteoporosis in postmenopausal women, approved in les than six months; and

* Rezulin and Prandin, medications to treat patients with symbol II diabetes, also approved in les than six months

The CDER also increased its approvals of generic medications and antibiotics that are not user absolute title [i]or[/i] posession supported. The total of approved generic medications in 1997 was 431--the highest number of generic approvals in this decade and up 80 from 1996 The decrease in medication approval times throw backs the importance of the agency's managerial reforms and the additional resources provided by means of the industry under the Prescription put drugs into User Fee Act (PDUFA) of 1992 Recognizing PDUFA's contribution, Congres further enhanced the user fee-simple program and extended it for another five years. The FDA Modernization Act of 1997 calls for still shorter review times and defines novel administrative goals designed to further accelerate the medication unfolding process.

FDA Drug Approvals in 1997 risk New Records (press release, Rockville, Md: US diet end Drug Administration, Jan 14 1998) 1-3

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