FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
News|Articles|March 15, 2020
- Pharmaceutical Technology-03-15-2020
- Volume 2020 eBook
- Issue 1
ALCOA+ and Data Integrity
Author(s)Susan J. Schniepp
Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.
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Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook, March 2020
March 2020
Pages: 10–13
Citation
When referring to this article, please cite it as S. J. Schniepp, “ALCOA+ and Data Integrity," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2020).
Articles in this issue
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A ‘New Normal’ for Quality?over 6 years ago
Monograph Development: Why and When to Participate (eBook)over 6 years ago
A Practical Approach to Pharmacopoeia Compliance (eBook)over 6 years ago
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