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Application Communications – Quality Assessment Perspective

Heidi Lee, PharmD, Branch Chief for the Office of Program and Regulatory Operations, discusses ANDA communications during quality assessment, best practices for submitting responses to the communications, and frequently asked questions (with answers).
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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