FY 2021 Generic Drug Science and Research Initiatives
June 23, 2021
8:30 a.m. – 4:45 p.m. (EST, UTC-5)
This event is FREE
The purpose of the public workshop is to provide an overview of the status of current science and research initiatives for generic drugs and an opportunity for public input on these initiatives. The public workshop also fulfills FDA’s commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its FY 2022 GDUFA Science and Research Priority Initiatives.
The workshop includes three interactive breakout sessions with speakers from the generic drug industry and a panel discussion.
Session 1: Model-Integrated Evidence for Generic Drug Development will focus on:
- Assessing the regulatory utility and knowledge gaps related to implementing modeling and simulation (e.g., computational fluid dynamics coupled with PBPK models) for orally-inhaled products.
- Leveraging model integrated evidence for long-acting injectables to reduce regulatory barriers.
- Identifying opportunities and challenges for utilizing artificial intelligence (e.g., machine learning and natural language processing) to support generic drug development and review.
Session 2: Complex Product Characterization and Analysis will focus on:
- Exploring the main gaps that industry and others see in complex generic product characterization and analysis, and clarifying the types of products that should have more focus.
- Discussing which new analytical methods are promising for generic drug development, screening, quality surveillance, etc. These discussions will consider access and availability by industry, cost, and acceptance, and identify which plans or considerations need to be put in place to encourage adoption of new technologies by the generic drug industry.
- Assessing analytical methods currently seen to be most useful, and discussing what can be done to better develop these technologies. The rationale for sampling and the numbers of batches to assess for batch-to-batch variability for various types of complex products will also be discussed.
Session 3: In Vitro and In Vivo Bioequivalence Approaches: Challenges and Opportunities will focus on:
- Considering the utility of in vitro characterization and modeling approaches to support biowaivers for certain (e.g., non-Q1/Q2) formulations of prospective generic products.
- Discussing the design, conduct and data analysis of in vivo bioequivalence studies, including the study design and the selection of appropriate subject or patient populations for studies that support a demonstration of bioequivalence for complex products, including oncologic products.
Full Agenda Coming Soon
The Agenda is being finalized and will be posted here as soon as it is ready.
The speaker biographies document is being finalized and will be posted here as soon as it is ready.
The virtual conference will be hosted via Adobe Connect and is limited to 3,000 simultaneous attendees (1,000 in each of the Breakout Session tracks). If a room is full when you attempt to enter, please try another room. The recordings of each of the Breakout Session tracks will be posted below within 24 hours.
The links below to the Adobe Connect rooms will be activated shortly before the event begins.
Please select a room based on the Breakout Session track that most interests you:
(All three rooms will broadcast the shared morning sessions)
The above rooms will open ~15 minutes before the Workshop begins.
If you encounter any technical issues, visit the Technical Issues Support Page
The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.
To test your PC, please visit:
The ZIP file above will be available for download 24 hours before the event.
Link to Final Evaluation & Certificate of Attendance
The above link will become active at the conclusion of the event.
Links to recordings will be added here as they become available.
Continuing Education Credit
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. There is a maximum of 12 credits per two-day event.
- 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.
If you have questions regarding the content of the event or other CDER-specific information, please: