This conference discussed the two Drug Master File (DMF) enhancements specified under the Generic Drug User Fee Amendments (GDUFA) III Commitment Letter which includes DMF review prior to ANDA submission and assessment of solicited DMF amendments outside of an application.
Timestamps
03:38 – The Future of FDA Quality Assessment Knowledge-Aided Assessment & Structured Application - KASA
25:10 – Modernization of Regulatory Submission
49:42 – Quick Guide to Creating a Structure-Data File (SD File) for Submissions
01:08:07 – Q&A Discussion Panel
Speakers:
Andre Raw, PhD
Associate Director for Science and Communication
Office of Lifecycle Drug Products (OLDP)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | US FDA
Larisa Wu, PhD
Associate Director for Science and Communication
Office of New Drug Products (ONDP)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | US FDA
Marlene Kim
Chemist, Health Informatics Staff (HIS)
Office of Data, Analytics, & Research (ODAR)
Office of Digital Transformation (ODT)
Office of the Commissioner (OC)
Panelists:
Andre Raw, Larisa Wu, Marlene Kim and
Erin Skoda, PhD
Branch Chief
Division of Lifecycle API
Office of New Drug Products (ONDP)
Center for Drug Evaluation and Research (CDER) | US FDA
Barbara O. Scott
Review Chemist
Division of Lifecycle API
Office of New Drug Products (ONDP)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | US FDA
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