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Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence
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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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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Phone - (301) 796-6707 I (866) 405-5367
Presenters:
Bijal Patel, PharmD, BCPS
Division of Filing Review, OGD | CDER
Nnenna Nzelibe, PharmD, MPH, BCACP
Division of Filing Review, OGD | CDER
--------------------
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Phone - (301) 796-6707 I (866) 405-5367
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