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

Conference

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 YuDirector, 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 DansoCommander, 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, PhDSenior 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, PharmDSenior 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 andDavid SkanchyCommander, United States Public Health ServiceDirector 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, PhDBranch 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, PhDSenior 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, RPhCommander, 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, PhDSenior 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 andZiyang SuPolicy 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, PhDAssociate 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, PhDAssociate 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 KimChemist, 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 andBarbara O. ScottReview 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, PhDScientific 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, PhDChemist 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 andDavid GreenSenior 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 SkanchyCommander, United States Public Health ServiceDirector 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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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.

04/11/2023

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