Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence

Описание: 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

Learn more at: https://www.fda.gov/drugs/news-events...
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