investigational drug labelling

descriptionPublicationkeyboard_double_arrow_right Part of book or chapter of book , Other literature type 01 Jan 2009 English Publisher:Springer Vienna

Authors: Gerhard Nahler;

doi: 10.1007/978-3-211-89836-9_735

investigational drug labelling

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Abstract

The package of an investigational new drug intended for human use has to bear a label with a statement specific for the national regulations; EC: name and address of the company, identification of the substance or code, date of expiry/ retest, lot number, name of the responsible physician, to be used for clinical trials; US: “caution: new drug — limited by federal law to investigational use”.

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