The FDA has shelved its National Priority Voucher pilot, leaving sponsors that built CMC and launch-readiness plans around 1- to 2-month reviews facing uncertain timelines.
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).
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