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A Deep Dive: GDUFA III Scientific Meetings
Model-Informed and Model-Integrated Approach in BE Assessment of Long-Acting Injectable Products
AGDD 2024 | D2S05-1-Totality of Evidence Including Physiologically Based Pharmacokinetic Modeling...
GDF2025 – D1S17 - Pre-Abbreviated New Drug Application (ANDA) Meetings: Process and Best Practices
Expedited Investigational New Drug (IND) pilot program webinar
Advancing Generic Drugs Development: Translating Science to Approval 2023 - Day 2
GDUFA II Training - Pre ANDA Product Development Meetings, Robert Lionberger
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GDF 2024 | D1S15 - ANDA Project Management Topics: PLAIR and Cover Letter Attachments
Drug Master Files (DMFs) from an ANDA Perspective (7of28) Generic Drugs Forum – Apr. 3-4, 2019
GDF2025 – D1S12 - Considerations when Submitting Proposed Excipient Levels in IIG
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Last Updated: October 3, 2026
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Summary
This presentation provided an overview of the Presenters and a panel discuss exploring opportunities and challenges for utilizing artificial intelligence (e.g., machine learning ... This webinar will take an in-depth look into the following three types of scientific focused Satish Sharan from the Office of dissolution issues and examined OGD's bioequivalence evaluation based on the totality of The purpose of this public workshop is to communicate how In this presentation, Robert Lionberger will discuss the GDUFA II pre-ANDA This webinar provided an in-depth look into the draft guidance and explain the ICH EWG's current scientific thinking, and provide ... This session covered in detail the nuances considered for inactive ingredient (IIG) Controlled Correspondence reviews.
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