Conference

Event Title

Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions

November 30, 2022

Date:: November 30, 2022
Time:: 8:30 AM - 4:00 PM ET

Topics & Presentations	Speakers
Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions Keynote and Session 1
Keynote: Cloud-based Regulatory Submission and Assessment: ICH M4Q(R2) and FDA KASA Initiatives	Lawrence Yu Director, Office of New Drug Products (ONDP) Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) \| US FDA Rapporteur, ICH M4Q(R2) Expert Working Group
Closing out GDUFA II: Summary of DMF Performance	Benjamin Danso Commander, United States Public Health Service Regulatory Business Process Manager Office of Program & Regulatory Operations (OPRO) Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) \| US FDA
Introducing the DMF Enhancements in the GDUFA III Commitment Letter	Jayani Perera, PhD Senior Chemist Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) \| US FDA
GDUFA III Enhancements - Assessment of Solicited DMF Amendments	Jennifer Nguyen, PharmD Senior Regulatory Business Process Manager Office of Program and Regulatory Operations (OPRO) Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) \| US FDA
Q&A Discussion Panel	Benjamin Danso, Jayani Perera, Jennifer Nguyen and 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
Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions Session 2
GDUFA III DMF Prior Assessments: Explanation and Overview	Erin Skoda, PhD Branch Chief Division of Lifecycle API Office of New Drug Products (ONDP) Center for Drug Evaluation and Research (CDER) \| US FDA
GDUFA III Enhancements - DMF Prior Assessments	Jayani Perera, PhD Senior Chemist Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) \| US FDA
GDUFA III DMF Review Prior to ANDA Submission: Eligibility Criteria for the ANDA Submissions	Iain Margand, RPh Commander, United States Public Health Service Patent and Exclusivity Team, Division of Legal & Regulatory Support (DLRS) Office of Generic Drug Policy (OGDP) Office of Generic Drugs (OGD) Center for Drug Evaluation and Research (CDER) \| US FDA
GDUFA III Prior Assessment Process: Presumptive Q & A	Jayani Perera, PhD Senior Chemist Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) \| US FDA
Q&A Discussion Panel	Erin Skoda, Jayani Perera, Iain Margand, David Skanchy and Ziyang Su Policy Lead Division of Regulations, Guidance and Standards Office of Policy for Pharmaceutical Quality (OPPQ) Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) \| US FDA
Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions Session 3
The Future of FDA Quality Assessment Knowledge-Aided Assessment & Structured Application - KASA	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
Modernization of Regulatory Submission	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
Quick Guide to Creating a Structure-Data File (SD File) for Submissions	Marlene Kim Chemist, Health Informatics Staff (HIS) Office of Data, Analytics, & Research (ODAR) Office of Digital Transformation (ODT) Office of the Commissioner (OC)
Q&A Discussion Panel	Andre Raw, Larisa Wu, Marlene Kim, Erin Skoda and 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
Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions Session 4 and Closing Remarks
Improving (Q)SAR Review with Structure-Data Files (SD Files)	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
What are UNIIs and How Do You Get Them?	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
Machine Readable Synthetic Pathways in GSRS and KASA	Tyler Peryea Health Informatics Staff Office of Data, Analytics, And Research (ODAR) Office of Digital Transformation (ODT) Office of the Commissioner (OC) \| US FDA
Q&A Discussion Panel	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
Closing Remarks	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

Agenda

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ABOUT THIS EVENT

This conference is designed to cover two topics. First is to discuss 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. This topic will help the industry better understand the changes in GDUFA III and its potential benefits. Second is an update on the future state of DMF submissions and assessments including discussion of Knowledge-Aided Assessment and Structured Application (KASA), Structure-Data (SD) files and Global Substance Registration Systems (GSRS) database. This topic will inform the industry of the agency’s modernization effort in Chemistry Manufacturing and Controls (CMC) submission to further streamline the assessment process and make the approval process more efficient.

INTENDED AUDIENCE

Regulatory affairs and manufacturing professionals with an interest in understanding new DMF aspects of GDUFA III
Manufacturers of active pharmaceutical ingredients (APIs) in support of an ANDA or NDA (AAM, APIC, PhRMA, EFPAI, JPMA, DIA)
DMF holders and ANDA applicants looking to gain knowledge about structured data and SD file submission to the agency
Regulatory Affairs Professionals or Agents
Foreign Regulatory Bodies
Compendia (USP, EP, JP)

TOPICS COVERED

New GDUFA III DMF enhancements and their potential benefits to industry and the GDUFA program
KASA and structured data submission overview
Structure-Data (SD) files overview: what they are, how to create them and how they are used to improve Quantitative Structure-Activity Relationships (Q)SAR review
What a Unique Ingredient Identifier (UNII) is and how to get one
Structured Synthetic Route data with GSRS and KASA
Future state of CMC submissions

FDA RESOURCES

DMF Contact: [email protected]
DMF Submission
FDA Guidances
GDUFA III Information and Commitment Letter

KASA Resources

Lawrence X. Yu, Andre Raw, Larisa Wu, Christina Capacci-Daniel, Ying Zhang, and Susan Rosencrance "FDA’s New Pharmaceutical Quality Initiative: Knowledge-aided Assessment and Structured Applications” International Journal of Pharmaceutics (2019)
Presentation by Larisa Wu titled “Modernizing Drug Substance Assessment through KASA” from SBIA Drug Master File (DMF) and Drug Substance Workshop March 3 & 4, 2021

SD File Resources:

Questions on how to include the SD File in section S.3.2 of the eCTD: email [email protected]
Quick Guide to Creating a Structure-Data File (SD File) for DMF Submissions
Stop Re-drawing Chemicals! Implementation of
To obtain a UNII