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  4. FY 2021 Generic Drug Science and Research Initiatives Public Workshop - 06/23/2021 - 06/23/2021
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Webcast

Event Title
FY 2021 Generic Drug Science and Research Initiatives Public Workshop
June 23, 2021

Date:
June 23, 2021
Time:
9:00 AM - 5:00 PM ET

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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.

INTENDED AUDIENCE

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.

FDA RESOURCES

TECHNICAL INFORMATION AND QUESTIONS

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