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Impact of Data Integrity Issues on Pharmacology/Toxicology Studies in ANDAs

Victoria Keck, MS, VMD, Division of Clinical Review, discusses types of studies impacted by data integrity issues, common types of data integrity issues, key collaborations in identifying/investigating these issues, the impact of these issues on the review process, and how to manage the impact of the issues on the review process.
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/generic-drugs-forum-2021-lifecycle-generic-drug-04282021-04292021
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