Abstract
All marketed drugs and biologics are sold accompanied by the package leaflet (European Union [EU]) [1] or a package insert (Japan and the United States) [2–5], documents that describe product characteristics (active and inactive ingredients, chemical structure, formula, and pharmaceutical properties), summarize all known nonclinical and clinical information, and provide guidance for dosing and administration. The contents of these ‘labels’ represent the culmination of all research and development testing and of negotiations with the health authority from whom marketing approval is requested. For a marketed product, labeling documents constitute the primary method of communication with the physician prescribing the product.
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References
European Commission, Enterprise and Industry Directorate-General, A Guideline on Summary of Product Characteristics, October 2005. Revision 1.
Guidelines for Package Inserts for Prescription Drugs (Notification No. 606 of PAB dated April 25, 1997).
Guidelines for Package Inserts for Prescription Drugs (Notification No. 59 of the Safety Division, PAB datedApril 25, 1997).
Guidelines for Precautions for Prescription Drugs (Notification No. 607 of PAB dated April 25, 1997).
Title 21 — Food and Drugs Chapter I — Food and Drug Administration Department of Health and Human Services Subchapter C — Drugs: General Part 201 Labeling, Subpart B Labeling requirements for prescription drugs and/or insulin, Section 201.56 [71 FR 3986], January 24, 2006.
ICH Harmonised Tripartite Guideline E6(R1) Guideline for Good Clinical Practice: Consolidated Guidance, ICH June 1996, http://www.ich.org (Accessed 27 February 2007).
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© 2009 Birkhäuser Verlag Basel/Switzerland
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Wood, L.F. (2009). Investigator’s brochures. In: Wood, L.F., Foote, M. (eds) Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics. Birkhäuser, Basel. https://doi.org/10.1007/978-3-7643-8362-6_7
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DOI: https://doi.org/10.1007/978-3-7643-8362-6_7
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