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| home > epc > autumn 2004 > stimulating paediatric drug research: comparing the us and eu approaches - part i |
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European Pharmaceutical Contractor
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The 'off label' use of medications in paediatrics is widespread. As a result, an authorised drug may be dosed inappropriately, demonstrate absent or reduced efficacy, or produce unwanted or previously unknown adverse events. Legislative initiatives in the US address this problem by stimulating paediatric drug development through voluntary incentives (1) and required studies (2) involving children. Recently, the European Commission (EC) circulated a draft proposal that would establish a similar programme within the European Union (EU) (3). At issue is the proper ethical balance between protecting children from exposure to the risks of research versus the risks of using medications not tested in children. This commentary will compare and contrast the regulatory approaches that seek to strike a balance in the US and EU. In Part II, the adequacy of the comparative regulatory frameworks for the ethical review and approval of research involving children will be reviewed.
EC Draft Proposal
The EC draft proposal, similar to the US approach, seeks to stimulate paediatric drug development through 'a system of both obligations and incentives/rewards'. Following on from a public consultation conducted in 2002, the current EC draft proposal was distributed on 8th March 2004, with comments due by 9th April 2004. The proposed regulations are subject to an Extended Impact Assessment, which is currently underway.
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By Dr Robert M Nelson, MD, Associate Professor of Anaesthesia and Pediatrics, Department of Anaesthesiology and Critical Care Medicine at The Children's Hospital of Philadelphia, and the University of Pennsylvania
Dr Robert M Nelson, MD, is Associate Professor of Anesthesia and Pediatrics at The Children's Hospital of Philadelphia and the University of Pennsylvania School of Medicine. Receiving his MD degree from Yale University, Dr Nelson trained in Pediatrics (Massachusetts General Hospital), Neonatology and Pediatric Critical Care (University of California, San Francisco). In addition, he received a PhD in the study of religion from Harvard University. Dr Nelson consults to the Office of Human Research Protections and is a member of the Pediatric Research Subcommittee of the Secretary's Advisory Committee on Human Research Protections. Dr Nelson has been a member of the FDA Pediatric Advisory Subcommittee, the Committee on Clinical Research Involving Children of the Institute of Medicine, and is former Chair of the Committee on Bioethics of the American Academy of Pediatrics.
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Industry Events |
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News and Press Releases |
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Azopharma Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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