Advancing Generic Drug Development:
Translating Science to Approval
September 21-22, 2021
This conference is FREE
The purpose of the public workshop is to communicate how outcomes from FDA research conducted under the Generic Drug User Fee Amendments (GDUFA) guide and facilitate generic drug development, regulatory assessment, and approval. The 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 the science and cutting-edge methodologies behind generic drug development.
This workshop is part of the SBIA Regulatory Education for Industry (REdI) series and 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.
Sessions and topics will be divided across different product types and key topics present in today’s environment. Sessions will cover the following products and topics:
- Complex Injectables
- Nasal and Inhalation Products
- Ophthalmic and Otic Products
- Oral Dosage Forms
- Topical Dermatological Products
- COVID-19 Impact
- Cutting-Edge Science
Detailed Agenda Coming Soon
Who Should Attend:
Scientists, researchers and regulatory affairs professionals who work on or are interested in working on the development of generic drugs including complex generic products that are more challenging to develop.
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 2,000 simultaneous attendees. If a room is full when you attempt to enter, please try the other room.
The links below to the Adobe Connect rooms will be activated about 15 minutes before each day 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:
Each ZIP files above will be available for download ~24 hours before the Track begins.
Evaluation & Certificate of Attendance
The above link will become active at the end of the Workshop
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 a maximum of 12 credits per two-day event (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.
If you have questions regarding the content of the event or other CDER-specific information, please: