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FY2016 Regulatory Science Report: Database and Knowledge Management

FY2016 Regulatory Science Report: Database and Knowledge Management

This section contains only new information from FY2016. For background scientific information and outcomes from previous years on this research topic, please refer to the FY15 Regulatory Science Research Report on Database and Knowledge Management.

ORS staff facilitating research in this area

  • Andrew Babiskin, Meng Hu, Saranrat Wittayanukorn, Sarah Dutcher, Zhong Wang, Hong Wen, Liang Zhao, and other ORS staff members

Projects and Collaborators

  • Office of Bioequivalence, OGD
  • Division of Filing Review, OGD/ORO
  • Office of Computational Science, OTS
  • Other stakeholder offices across FDA

Publications and Presentations

  • [Poster]
    Tsakalozou E, Hu M, Zhang X, Babiskin A, Zhao L, Jiang W. Searchable Database of FDA Product-specific Recommendations Used to Establish Therapeutic Equivalence of Generic Drug Products. AAPS (2016)
  • [Poster]
    Wittayanukorn S, Babiskin A, Dutcher S, Pu X, Hu M, Zhao L, Lionberger R. Patterns of Bioequivalence Recommendations and Trends of Abbreviated New Drug Approval over Time. ISPOR (2016)
  • Irwin JJ, Pottel J, Zou L, Wen H, Zuk S, Zhang X, Sterling T, Shoichet BK, Lionberger R, Giacomini KM. A Molecular Basis for Innovation in Drug Excipients. CPT (Accepted 2016)
  • [Invited Speech]
    Wen H. “Overview of Inactive Ingredients”. LyoHub/NIPTE Fall Meeting, Gaithersburg MD (Sep 2016)

Outcomes

  • Searchable database of FDA product-specific bioequivalence recommendations
  • Database of reference-listed drug products organized by classification of various types of product and drug substance complexity
  • Development of the CERSI Excipients Browser (created by UCSF)

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