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Visit the CDER Small Business and Industry Assistance Webpage

This webinar is FREE.

This follow-on webinar will focus on answering attendee questions regarding the posters and presentations given at the Drug Master File (DMF) and Drug Substance Workshop on March 3-4, 2021. Questions received from industry before March 19, 2021, at [email protected] may be answered as well as questions submitted during the workshop. There will be an opportunity for live questions and panel discussion with subject matter experts.

There are also 19 poster presentations on a variety of topics. All are invited to view the poster presentations and submit questions for any of them to [email protected]. 

REVIEW POSTERS

 

 

 

TOPICS

• Information on submitting and managing DMFs, fee payments, and facility identification
• How to maximize communication tools offered by the agency to get answers to your questions
• What to consider for development of a complex API
• Process validation and ICH Q7
• How to select an appropriate regulatory starting material (ICH Q11 and Q11 Q&A)
• Expectations for impurity assessment ((Q)SAR & pharm-tox) and control (ICH Q3A, Q3C, Q3D, and M7)
• How to develop a robust chromatographic method for API release
• Expectations for Lifecycle Management of DMFs and the Draft Post-Approval Change Guidance
• Common mistakes and how to avoid them: case study examples
• Posters covering topics of interest

INTENDED AUDIENCE

• All participants of SBIA-DMF/Drug Substance Workshop of March 3 and 4, 2021.
• Manufacturers of active pharmaceutical ingredients in support of an ANDA or NDA (AAM, APIC, PhRMA, EFPAI, JPMA, DIA)
• Regulatory affairs professional or agents
• Outside testing facilities that provide data to support the safety (AMES Studies, (Q)SAR predictions, nitrosamine testing to support risk assessment) or quality (release or stability testers) of the active pharmaceutical ingredient in a DMF
• Outside manufacturing facilities that provide intermediates to be used in the manufacture of active pharmaceutical ingredients.
• Foreign regulatory bodies
• Compendia

FDA RESOURCES

• DMF Submission
• DMF Contact
• FDA Guidances
• ICH Quality

SLIDES

• Barbara Scott Introduction and Welcome! (PDF - 141.83KB)
• Presenter: Vathsala Selvam Session 1 Topics: Form 3938, Agent Appointment, Letter of Authorization, Pre-assigned DMF number, Annual Report, and Communications  (PDF - 506.12KB)
• Presenter: Anita Tiwari Session 2 Topic: ICH Q11 Q&A, a Supporting Document for the Selection and Justification of Starting Materials  (PDF - 656.09KB)
• Erin Skoda, Ph.D. Closing Remarks  (PDF - 144.88KB)

VISIT:

CDER Small Business and Industry Assistance

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