---

---

---

Agenda

Visit CDER Small Business and Industry Assistance Page

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: dmfogd@fda.hhs.gov
• 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 esub@fda.hhs.gov
• Quick Guide to Creating a Structure-Data File (SD File) for DMF Submissions
• Stop Re-drawing Chemicals! Implementation of
• To obtain a UNII

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

• To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
• Please contact info@sbiaevents.com for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support.
• Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.