Developing a target
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.
KeywordsEuropean Union Source Document Clinical Study Report Commercial Distribution Market Authorisation Application
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