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Meetings: Pre-submission and Special Programs (4of15) REdI Annual Conference – May 29-30, 2019
GDUFA II Training - Pre ANDA Program Pre Submission Meetings, Robert Lionberger
GDUFA II Training - Pre ANDA Product Development Meetings, Robert Lionberger
Good ANDA Submission and Assessment Practices and Software Support- FDA Generic Drug Forum 2018
Step-by-Step Process of Generic Drug Development for ANDA Submission
ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA
Good ANDA Submission and Assessment Practices and Software Support - FDA Generic Drug Forum 2018
ANDA Filing and Approval Process
GDUFA III MCRM External Training Presentation final
How to Prepare & Conduct Pre-Submission Meetings
Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions
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Last Updated: October 3, 2026
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Summary
In this webinar, FDA provided an overview of the types of This presentation provided an overview of the This presentation described the purpose and scope of pre- Timestamps 01:13 – Introduction to Callie Cappel-Lynch from CDER's Office of In this presentation, Robert Lionberger will discuss the Step-by-Step Process of Generic Drug Development for FDA revised the final guidance for industry entitled, “ Have you considered soliciting feedback from FDA for your medical device? How should you approach the James Hanratty from the Office of Generic Drugs, discusses the guidance for industry entitled “Referencing
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