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23:35
YouTube
U.S. Food and Drug Administration
Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence
FDA discusses an overview of common deficiencies found during the filing review and recommendations for best practices for submitting controlled correspondences and substantially complete ANDAs. Presenters: Bijal Patel, PharmD, BCPS Division of Filing Review, OGD | CDER Nnenna Nzelibe, PharmD, MPH, BCACP Division of Filing Review, OGD | CDER ...
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May 13, 2021
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