Showing papers by "Tufts Center for the Study of Drug Development published in 1999"
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TL;DR: The European Agency for the Evaluation of Medicinal Products (EMEA) was established in July 1993 to unify regulatory practices and improve market access within the European Union (EU). In February 1995, the EMEA implemented the centralized procedure for drug approval within the EU and examined the time to obtain product marketing authorization for products that have gone through the process relative to the goals set for the program at its inception.
Abstract: The European Agency for the Evaluation of Medicinal Products (EMEA) was established in July 1993 to unify regulatory practices and improve market access within the European Union (EU). In February 1995, the EMEA implemented the centralized procedure for drug approval within the EU. The current study explores the history, goals, and implementation of the centralized procedure. We examine the time to obtain product marketing authorization for products that have gone through the process relative to the goals set for the program at its inception, and we compare approval times for a group of products that have been approved by both the EMEA and the United States Food and Drug Administration (FDA). Our data indicate that the goals established by the EMEA for the timeliness of application review have generally been met. Moreover, mean approval times for products approved by both the EMEA and the FDA were similar.
28 citations
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TL;DR: One of the many provisions of the recently enacted Food and Drug Administration Modernization Act (FDAMA) provides for an additional period of market exclusivity in exchange for completed pediatric studies requested by the FDA for certain drugs of potential benefit to the pediatric population.
Abstract: One of the many provisions of the recently enacted Food and Drug Administration Modernization Act (FDAMA) provides for an additional period of market exclusivity in exchange for completed pediatric studies requested by the FDA for certain drugs of potential benefit to the pediatric population. The impetus for this law centers around two facts: Drugs needed in the pediatric population lack labeling for pediatric use, and industry lacks incentive to perform studies to support this additional labeling. Congress has now provided the incentive. The success of the pediatric initiative will rest initially on industry's willingness and readiness to do the studies. This willingness, in turn, will depend on FDAMA's impact on the economics of drug development and the availability of pediatric research capacity, both of which could be affected by the FDA's final rule on the assessment of safety and effectiveness of drugs and biologicals for pediatric patients. This rule will compel firms to conduct pediatric studies similar to the ones encouraged under FDAMA's voluntary pediatric exclusivity program. Although the Act provides for the statutory harmonization of the rule with the Act, whether the effects of the rule on the Act have been fully contemplated is a premise considered in this article. Congress too has much to contemplate as they evaluate the FDA's report, due in less than 2 years, on the public health effectiveness and economic effects of the Act's incentive program in preparation for possible FDAMA II modifications.
14 citations