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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