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Agenda

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ABOUT THIS CONFERENCE

The purpose of this public workshop is to communicate how FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program outcomes guide and facilitate generic drug development, regulatory assessment, and approval. This workshop will focus on common issues seen in abbreviated new drug applications (ANDAs), link GDUFA science and research on complex products and scientific issues to product-specific guidance development, and pre-ANDA meeting discussions, and examine various areas of innovative science and cutting-edge methodologies behind generic drug development. This workshop will also provide some insight into upcoming GDUFA III enhancements.

 

 

TOPICS COVERED

• Peptide and Oligonucleotide Active Pharmaceutical Ingredient (API) Sameness and Impurity Assessment Considerations
• Drug-Device Combination Products
• Long-Acting Injectables
• Oral Complex Drug Products
• Nasally Administered Products
• Quantitative Methods and Model-Integrated Bioequivalence Approaches
• Suitability Petitions

INTENDED AUDIENCE

Scientists, researchers, current and prospective generic drug applicants, and regulatory affairs professionals who work on or have an interest in the development of generic drugs, including complex generic products.

LEARNING OBJECTIVES

• Comprehend new developments in science, guidance, and regulatory assessment experience for generic drug products
• Understand FDA’s perspectives, research, and regulatory assessment relating to generic drug development
• Apply various mechanisms and methodologies that drug developers can use to facilitate generic drug development

FDA RESOURCES

• Industry Resources
• Pre-ANDA Program
• GDUFA Science and Research
• Product-Specific Guidances for Generic Drug Development
• Guidances Related to Generic Drugs (under topics, choose “generic drugs”)
• Federal Register Notices Related to Generic Drugs
• GDUFA III

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

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