Advancing Generic Drug Development:
Translating Science to Approval
September 21-22, 2021
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.
The agenda may be updated if any changes occur. The current version is Version 8, updated on September 18, 2021.
The speaker biographies document is being finalized and will be posted here as soon as it is ready.
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: