- June 23, 2021
9:00 AM - 5:00 PM ET
Subscribe to be notified when registration is open.
This conference is FREE and part of the SBIA Regulatory Education for Industry (REdI) series.
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. FDA will take the information it obtains from the public workshop into account in developing its FY 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research Initiatives.
FDA is particularly interested in receiving input from industry and other interested stakeholders on the following five topic areas:
- What research is needed to determine how formulation differences in generic injectable products (that are not qualitatively (Q1) and quantitatively (Q2) the same as their reference listed drug products) affect the substitutability of these products?
- What research is needed to prepare for generic versions of oligonucleotide drug products (e.g., siRNA, chemically modified, antisense oligonucleotides)?
- What research relating to artificial intelligence (including machine learning) and/or the use of big data toolsets may facilitate and modernize the development of generic products?
- What research is needed to bridge the gap between existing scientific insights from GDUFA-funded research (e.g., related to product characterization techniques or modeling and simulation tools) and the development of suitable test procedures, study designs, model integrated evidence, and/or approaches for developing generic products?
- What research is needed to support best practices and convergence of global bioequivalence standards?
Specific presentations and discussions at this workshop will be announced at a later date and may differ from the topics above.
Generic drug industry stakeholders including scientists/researchers, clinicians, regulatory affairs professionals, and patient advocates who work on or are interested in research that advances the development of generic drugs.
TECHNICAL INFORMATION AND QUESTIONS
- To optimize webinar experience, use Chrome when viewing AdobeConnect in a browser.
- Please contact firstname.lastname@example.org for all technical questions.
- If you encounter any technical issues before or during the event, please visit the Technical Issues Support Page for help.
- Test your PC for use with Adobe Connect prior to the day of the event.
Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.