An investigational product is a
pharmaceuticalform of an active ingredient or placebobeing tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. This has been referred to by the National Center for Policy Analysisas [http://www.ncpa.org/sub/dpd/index.php?page=article&Article_ID=13786 open access] to such drugs.
European Medicines Agency
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