FDA's drug review process and the package label strategies for writing successful FDA submissions /
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 li...
Main Author: | Brody, Tom, |
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Other Authors: | ScienceDirect (Online service) |
Format: | eBook |
Language: | English |
Published: |
Cambridge, MA :
Academic Press,
2017.
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Physical Description: |
1 online resource. |
Subjects: |
CMU Electronic Access
Electronic Resource Click HereLocation | Call Number: | Status |
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CMU Electronic Access | Available |