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Supporting Events from FDA CDER Small Business & Industry Assistance

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Drug Master File (DMF) and Drug Substance Workshop
March 3 & 4, 2021
7:45 a.m. – 4:30 p.m. (EST, UTC-4)

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This event is FREE

Via Webcast

Ensuring high quality and manufacturing integrity of Active Pharmaceutical Ingredients (APIs) requires understanding and incorporation of quality and risk management principals throughout the API lifecycle. This conference is designed to provide an update on current Agency initiatives and will cover a wide variety of topics of interest to API manufacturers and regulators. Specifically, the Agency wishes to provide guidance on the DMF submission process and expectations for content through a series of presentations, panel discussions, and Q&A for two poster sessions. The desired outcome is to outline the various regulatory steps necessary for the successful development of a high-quality submission of drug substance information to the Agency.

See the Full Agenda


Follow-Up Q&A Webinar on April 9

This Workshop Includes a Follow-Up Webinar!

When you register for this Workshop, you will also be registered for the Follow-Up Q&A Webinar to be held on April 9, 2021 from 1:00 – 4:00 PM Eastern (UTC-4). Please add it to your calendar if you would like to attend! A reminder email with login information will be sent 24 hours before the webinar begins.

This follow-on webinar will focus on answering attendee questions regarding the posters and presentations given during the DMF Workshop. Additional questions sent to before March 19, 2021, may also be answered during the follow-up webinar. There will be an opportunity for live questions and panel discussion with subject matter experts.

Not registered for this Workshop, but you would like to register for the follow-up webinar? Click Here.

Virtual Attendance Information

The virtual conference will be hosted via Adobe Connect and is limited to 2,000 simultaneous attendees (1,000 each in Room One and Room Two). If a room is full when you attempt to enter, please try the other room. The recordings of each of the sessions will be posted below within 24 hours.

The links below to the Adobe Connect rooms will be activated shortly before the event begins.

Please select the correct room based on the first letter of your LAST NAME.

Last Name A – K

Last Name L – Z

The above rooms will open ~15 minutes before each day begins.

If you encounter any technical issues, visit the Technical Issues Support Page

The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.

To test your PC, please visit:

Agenda & Speaker Bios

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Event Agenda

The agenda may be updated as changes to the schedule occur. The currents version is Version 4, updated on January 8, 2021.

PDF Download
Speaker Biographies

The speaker biographies document provides information on the speakers participating in the Workshop.

Files, Certificate & Recordings

The ZIP files above will be available for download 24 hours before the event.

Link to Final Evaluation & Certificate of Attendance

The above link will become active at the conclusion of the event.

Session Recordings:

Links to recordings will be added as they become available.

Day One:

  • Welcome – Lawrence Yu
  • Introduction to the DMF Review Process – Erin Skoda
  • Administrative Aspects of Managing a DMF – Vathsala Selvam
  • Q&A Panel for above sessions
  • Managing Electronic DMF Submissions – Jonathan Resnick
  • Drug Master Files from a GDUFA II User Fee Perspective – Hanah Pham & Evelyn Hong
  • ITimely Consult and Early Information Request (TCIR) Process for Drug Master Files (DMFs) – Jayani Perera
  • Effective Communication Strategies for Drug Master Files (DMF) – David Skanchy & Benjamin Danso
  • Q&A Panel for above sessions
  • Poster Presentations: Responses to Submitted Questions (Day One)
  • Drug Substance Facilities – Hidden and Critical Intermediate – Cassandra Abellard & Wei Liu
  • ICH Q11 Q&A, a Supporting Document for the Selection and Justification of Starting Materials – Anita Tiwari
  • Q&A Panel for above sessions
  • Common Issues Related to LC and GC Methods in Type II DMFs – Xinghua Wu
  • Process Validation and ICH Q7 – David Amspacher
  • Regulatory Considerations in Demonstrating Complex API Sameness – Bapu R. Gaddam
  • Q&A Panel for above sessions

Day Two:

  • Regulatory Considerations for Impurity Qualification: ICH Q3A/Q3C/Q3D, RLD & MDD – Hongbiao Liao
  • ICH M7(R1) – Chemistry and Manufacturing Control (CMC) Perspective on Hazard Assessment – Barbara O. Scott
  • Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification – Naomi L. Kruhlak
  • Q&A Panel for above sessions
  • Safety Evaluation of Drug Substance Impurities in Generics – Chanchal Gupta
  • Nitrosamines: Where Are We Now? – Deborah F. Johnson
  • Q&A Panel for above sessions
  • Poster Presentations: Responses to Submitted Questions (Day Two)
  • API Facility Inspections – Jay Jariwala
  • Drug Substance Postapproval Changes Guidance: Determination of Impurity Profile Equivalence – Brian Connell
  • Q&A Panel for above sessions
  • Common CMC Issues in Type II DMFs and How to Avoid Them – Wei Liu
  • Modernizing Drug Substance Assessment through KASA – Larisa Wu
  • Q&A Panel for above sessions

Poster Presentations

In addition to the presentations during the 2-day Conference, there are 19 pre-recorded Poster Presentations on a variety of topics. You are invited to view the poster presentations and submit questions for any of them. The questions received before February 15 have been reviewed and will be addressed during the “Poster Presentations: Responses to Submitted Questions” sessions during the Conference. Questions that are received by March 19, will be reviewed and addressed during the Follow-Up Webinar on April 9, 2021.

* Download PDFs of the Posters *

NOTE: The “Submit a Question” buttons below should add a Subject to the email that includes the Poster number.
Some browsers may strip that Subject line.
If that occurs, please add the Poster number to the email Subject line before you send your question.

The Poster Presentations

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1. Timeline for the DMF review process (basic primer on how we align with ANDA)

Authors: Wei Song, Steve Kinsley. Alignment of the DMF review process with the ANDA review process and timelines will be covered.

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2. Completeness Assessments (CAs): Current CA Status, KASA for CA, Common Issues & GDUFA Commitment Letter Statistics

Authors: Yingzi Wang, Jayani R. Perera, Jason Crawford, Larisa Wu, and Xiang Yu. This poster discusses CA statistics, application of KASA, and advice for improving the CA outcome.

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3. Metrics on DMF Assessments

Authors: Steve Kinsley, Wei Song. DMF statistics including adherence to due dates and overall productivity will be presented.

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4. Introduction to FDA Drug Master File Form 3938

Authors: Vathsala Selvam and CDR David Skanchy. The new FDA DMF form 3938, similar to the application 356h form, will be presented. View full 29-minute full length webinar: Drug Master Files(DMF) Submissions on New FDA Form 3938

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5. Cocrystal APIs: Recommended Documentation

Authors: Weiqin Jiang, Neeru Takiar, and Ramnarayan Randad. A discussion of API sameness with regard to cocrystal APIs will be covered.

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6. Synthetic Therapeutic Polymers: Recommended documentation for API sameness

Authors: Bapu R. Gaddam, Ramnarayan Randad, Benjamin Lim, David Skanchy. Regulatory strategies to establish API sameness of cross coupled polymers.

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7. Synthetic Therapeutic Peptide APIs: Recommended documentation for API sameness & related impurities

Authors: Suresh Jayasekara, Manivannan Ethirajan, David Green, and Ramnarayan Randad. Practical advice on achieving API sameness in peptide drug substances is provided.

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8. Regulatory Considerations for Synthetic and Semi-synthetic Oligosaccharide Complex APIs in Generic Products

Authors: Keduo Qian, Barbara Scott, Govindaraj Kumaran, Weixiang Dai, CDR David Skanchy. We will present the Agency’s current thinking on the active ingredient sameness assessment of oligosaccharide complex APIs in generic and reference products.

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9. Quality Considerations for Continuous Manufacturing of APIs

Authors: Anjali Bain, Yun J. Wang, Ramnarayan Randad, David Skanchy, Adil Mohammad, Raymond Frankewich, and Thomas O’Connor. This poster is based on the draft guidance Quality Considerations for Continuous Manufacturing and provides information regarding FDA’s current thinking on the quality considerations for continuous manufacturing of small molecule drug substances.

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10. ANDA Aligned Teams

Authors: Steve Kinsley, Wei Song. The new Integrated Quality Assessment (IQA) alignment of teams to facility collaborative review will be presented.

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11. Review of Secondary Type II Drug Master Files

Authors: Madhusudhan Gowravaram & David Skanchy. This poster will discuss the risk-based review approach for the acceptance of secondary DMFs for the adequacy of primary DMFs supporting A/NDAs and some regulatory aspects of secondary DMFs.

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12. USP Pending Monograph Process and USP compliance for Industry

Authors: Yan Ma, Yun J. Wang, Anita Tiwari, Barbara Scott. This poster provides information on FDA’s current thinking on the USP-PMP and recommendations for drug master file (DMF) holders.

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13. Evaluation of Metal Impurities in Drug Substances

Authors: Donglei Yu, Mst Hasina Akter, Wei Liu, Ramnarayan Randad. The risk assessment for elemental impurities in drug substances and atypical drug substances will be discussed.

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14. Mutagenic Impurities from a Drug Substance Perspective: Highlights from the ICH M7 Question and Answer Draft Document

Authors: David Green, Barbara Scott, CDR David Skanchy. We will highlight four topics covered in the new ICH M7 Question and Answer Draft Document surrounding the control of mutagenic impurities.

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15. Establishing Impurity Acceptance Criteria as Part of Specifications for DMFs Based on Clinical Relevance

Authors: Yongjun Gao, Ramnarayan Randad, David Green, Weixiang Dai, Hongbiao Liao and David Skanchy. Advice on establishing impurity limits in various cases is provided.

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16. API Manufacturing Global Distribution and Facility Profile Analysis

Authors: Wei Song, Ying Zhang, Nathan Chen, and CDR David Skanchy. We will discuss the diverse and complex global API supply chain.

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17. Communications with DMF Holders and Applicants throughout the DMF Lifecycle

Authors: Fatima C. Sequeira, Vathsala Selvam, Claude Theophin, Terrence Nichols, Ben Danso, David Skanchy. We will review available pathways, that DMF holders and applicants can communicate with Agency.

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18. The DMF Teleconference Process

Authors: Benjamin Danso and Jayani Perera. The current process for requesting, granting, and executing a DMF teleconference will be described along with data and metrics for the process from GDUFA I to present.

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19. List of Relevant Quality Guidances & Common Deficiencies Observed during Drug Master File Review

Authors: Sad Ahamed and Mahmut Levent. This poster provides a non-exhaustive list of relevant technical guidance applicable to DMFs and discuss common deficiencies.

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Questions & More Information

Continuing Education Credit

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 Workshop:

  • has been pre-approved by RAPS as eligible for credits (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • has been 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.
  • has been 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.
  • has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.


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More Information

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