Monograph Development: Why and When to Participate (eBook)

Author(s)J. Mark Wiggins, Joseph A. Albanese

Monographs are developed based on the submission of information and materials from a company having regulatory approval for the product, and this submission feeds into the pharmacopoeia revision process.

Pharmacopoeia Compliance Series

This article explores another proactive advocacy approach that a bio/pharmaceutical company may take through participation in the development of new and revised monographs in the various pharmacopoeias.

This article is part of a series that will be published in 2019–2020. View all articles in this series.

Read this article in BioPharm International’s March 2020 Regulatory Sourcebook.

Article Details

BioPharm International
eBook: Regulatory Sourcebook, March 2020
March 2020
Pages: 12–24

Citation

When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Monograph Development: Why and When to Participate," BioPharm International Regulatory Sourcebook eBook (March 2020).

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