- May 5, 2021
9:00 AM - 12:30 PM ET
This webinar is FREE.
FDA will provide an overview of Product-Specific Guidances (PSGs), including how they are developed and revised and their role in facilitating generic drug development and generic drug application review. FDA will also discuss ways prospective and current generic drug applicants can use PSGs, including those for complex products, to improve the efficiency of generic drug development.
This webinar is being offered as part of FDA’s Drug Competition Action Plan, which aims to increase competition and make it easier and more efficient for drug developers to bring more generics into the marketplace, while maintaining FDA’s high standards for quality and scientific rigor.
- Describe general principals of PSGs
- Discuss the process of how PSGs are developed and revised
- Describe how FDA communicates current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs through PSGs
- Understand how PSGs and other pre-submission communications facilitate generic drug development and generic drug application assessment.
Rob Lionberger, Director, ORS/OGD
Lei Zhang, Deputy Director, ORS/OGD
CDR Christine Le, PSG Program Manager (Acting), ORS/OGD
Myong-Jin Kim, Deputy Division Director, Division of Quantitative Methods and Modeling, ORS | OGD
Markham Luke, Division Director, Division of Therapeutic Performance (DTP) | ORS | OGD
Mitchell Frost, Team Lead, DTP | ORS |OGD
Paramjeet Kaur, Staff Fellow, OB/OGD
David Coppersmith, Regulatory Counsel, OGDP/OGD
Generic drug industry stakeholders including current and potential applicants who are interested in submitting an application for generic drug development.
- Product-Specific Guidances for Generic Drug Development (main page)
- Product-Specific Guidances for Generic Drug Development (database)
- Upcoming Product-Specific Guidances for Complex Generic Drug Product Development
- Guidance for Industry, Bioequivalence Recommendations for Specific Products (Jun. 2010)
- Guidance for Industry, Referencing Approved Drug Products in ANDA Submissions (Oct. 2020)
- Guidance for Industry, Controlled Correspondence Related to Generic Drug Development (Dec. 2020)
- Guidance for Industry, Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA (Nov. 2020)
- FDA Drug Competition Action Plan
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.
- 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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