What the paediatricians need--the launch of paediatric research in Europe.
Most parents and many paediatricians are not aware that medicines for children are often not tested, labelled, or approved for their prescribed use. In 1997, the Food and Drug Administration developed incentives for pharmaceutical companies to perform paediatric research in medications. The European Commission brought out its proposal for paediatric incentives after in-depth internal reflection. Now it should be adapted quickly to boost pharmaceutical paediatric research in the EU as soon as possible.


CONCLUSIONS
The proposal must be balanced and aware that both incentives and requirements are mandatory in order to maintain and stimulate paediatric research on medicines in Europe.
Ramet
José
J
Paediatric Intensive Care Unit, Academisch Ziekenhuis, Vrije Universiteit Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium. ramet@skynet.be
D002648:Child; D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D004348:Drug Labeling; D005060:Europe; D033161:Government Regulation; D006801:Humans; D010372:Pediatrics; D014481:United States; D014486:United States Food and Drug Administration
Ann Oncol. 2003 Jan;14(1):1-5
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