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Abstract

Regulatory writing is an integral part of the health-product development process. Most nations have a governmental authority (also called a regulatory agency) responsible for determining whether a drug or biologic is sufficiently safe to allow commercial distribution. The product’s manufacturer must provide written documentation to this regulatory agency (called a submission) making an argument for safety and efficacy of the product. The regulatory agency, if it approves of the data and the claims, will file the submission and grant marketing approval. Regulatory writing is the discipline responsible for development of these regulatory documents.

Keywords

European Union Source Document Clinical Study Report Commercial Distribution Market Authorisation Application 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Birkhäuser Verlag Basel/Switzerland 2009

Authors and Affiliations

  • Linda Fossati Wood
    • 1
  1. 1.MedWrite, Inc.WestfordUSA

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