FDA Will Be Pressed to do More With Less, According to the Tufts Center for the Study of Drug Development.Business Editors/Health/Medical Writers BOSTON--(BUSINESS WIRE)--Jan. 13, 2004 Pressure on the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to maintain staff expertise will grow during 2004 as experienced agency staff retire or change jobs, and fewer new product applications limit funds available for new hires, according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the Tufts Center for the Study of Drug Development. Adding to the FDA's burden is an expanded mission to implement counter-bioterrorism activities, review increasingly complex new product applications, and expand post-market safety vigilance, the Tufts Center reported in its recently released Outlook 2004 report on drug and biotech development trends. "FDA personnel and resources will be under growing stress to carry out its primary mission to ensure the marketing of safe and effective medicines in the U.S.," said Tufts Center Director Kenneth I Kenneth I (Kenneth mac Alpin), d. 858, traditional founder of the kingdom of Scotland. He succeeded his father, Alpin, as king of Dalriada (the kingdom of the Gaelic Scots in W Scotland) and c. Kaitin. He added, "Drug developers are now expected to include more extensive data sets when submitting new drug applications, and the FDA is faced with the formidable challenge of evaluating this information efficiently without slowing down the approval process." The Tufts Center's Outlook 2004 also notes: -- The FDA will expand the scope of diseases and conditions eligible for fast track designation as a way to triage triage Division of patients for priority of care, usually into three categories: those who will not survive even with treatment; those who will survive without treatment; and those whose survival depends on treatment. its workload beyond assigning priority or standard review status to new drug applications. -- The FDA's intent to address emerging technologies, such as gene therapy, combination products, and pharmacogenomic data, will spawn major new regulatory initiatives. -- The European Agency for Evaluation of Medicinal Products medicinal product, n a substance administered to humans or animals through injection, application, oral ingestion, inhalation, and so forth, whose purpose is to ultimately restore health or eliminate disease in an individual. , the FDA's counterpart in Europe, will push hard to implement regulatory initiatives. They include providing more scientific advice to companies, facilitating global marketing applications by developing harmonized har·mo·nize v. har·mo·nized, har·mo·niz·ing, har·mo·niz·es v.tr. 1. To bring or come into agreement or harmony. See Synonyms at agree. 2. Music To provide harmony for (a melody). guidelines specific to therapeutic areas, and promoting early access of needed medicines through provisional marketing authorizations and accelerated reviews. About the Tufts Center for the Study of Drug Development The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University Tufts University, main campus at Medford, Mass.; coeducational; chartered 1852 by Universalists as a college for men. It became a university in 1955. Jackson College, formerly a coordinate undergraduate college for women, merged with the College of Liberal Arts in provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Based in Boston, the Tufts Center conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia sym·po·si·a n. A plural of symposium. , workshops, and public forums on related topics. |
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