Скачать или смотреть 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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