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cover of the book FDA’s drug review process and the package label : strategies for writing successful FDA submissions

Ebook: FDA’s drug review process and the package label : strategies for writing successful FDA submissions

Author: Brody Tom

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29.01.2024
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FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one  Read more...
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