[Regulatory aspects of the drug authorization for children. USA, Europe and Germany].
Franken
Andreas
A
Clinical Research/eSubmission, Bundesverband der Arzneimittel-Hersteller e.V. (BAH), German Medicines Manufacturers Association, Ubierstr. 71-73, D-53173 Bonn. franken@bah-bonn.de
D002648:Child; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005060:Europe; D005858:Germany; D006801:Humans; D007880:Legislation, Drug / Q000639:trends*; D014481:United States; D014486:United States Food and Drug Administration; D014944:World Health Organization