DMF Workshop: GDUFA III Enhancements and Structured Data Submissions – Session 4 and Closing Remarks

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

02:40 – Improving (Q)SAR Review with Structure-Data Files (SD Files)

25:43 – What are UNIIs and How Do You Get Them?

35:12 – Machine Readable Synthetic Pathways in GSRS and KASA

01:01:01 – Q&A Discussion Panel

01:24:20 – Closing Remarks

Speakers:

Naomi L. Kruhlak, PhD
Scientific Lead
Computational Toxicology Consultation Service (CTCS)
Division of Applied Regulatory Science (DARS)
Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS) | CDER

Frank L. Switzer, PhD
Chemist
Health Informatics Staff
Office of Data, Analytics, And Research (ODAR)
Office of Digital Transformation (ODT)
Office of the Commissioner (OC) | US FDA

Tyler Peryea
Health Informatics Staff
Office of Data, Analytics, And Research (ODAR)
Office of Digital Transformation (ODT)
Office of the Commissioner (OC) | US FDA

David Skanchy
Commander, United States Public Health Service
Director
Division of Lifecycle API (DLAPI)
Office of New Drug Products (ONDP)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | US FDA

Panelists:

Naomi Kruhlak, Frank Switzer, Tyler Peryea and

David Green
Senior Pharmaceutical Quality Assessor
Division of Life Cycle API (DLAPI)
Office of New Drug Product (ONDP)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | US FDA

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

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