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...

Full description

Main Author: Brody, Tom,
Other Authors: ScienceDirect (Online service)
Format: eBook
Language: English
Published: Cambridge, MA : Academic Press, 2017.
Physical Description: 1 online resource.
Subjects:

CMU Electronic Access

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