Abstract
Official letter of the FDA to a sponsor company, informing e.g. on an NDA decision by the agency; three types exist: (i) an approval letter which allows marketing of the product, (ii) an approvable letter which lists minor issues to be resolved before a definite approval, (iii) a not approvable letter which describes important deficiencies that preclude approval unless corrected; → see also new drug application.
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© 2009 Springer-Verlag/Wien
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Nahler, G. (2009). action letter. In: Dictionary of Pharmaceutical Medicine. Springer, Vienna. https://doi.org/10.1007/978-3-211-89836-9_15
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DOI: https://doi.org/10.1007/978-3-211-89836-9_15
Publisher Name: Springer, Vienna
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