GDUFA Research Outcomes

Ophthalmic-Otic Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the ophthalmic or otic route, including solutions, suspensions and other dosage forms.

• All(162)
• Posters(65)
• Presentations(34)
• Papers(63)

• Novel In Vitro, Ex Vivo and In Vivo Assessment of Ophthalmic Semi-Solid Drug Products

  Lu, Xiuling

• Considerations for Post-Approval Changes to Complex Generic Drug Products

  Kozak, Darby

• A Scientific and Regulatory Overview of IVRT: Current Considerations and Challenges

  Kozak, Darby

• Approaches Using Proactive Research in Support of Product-Specific Guidance (PSG) Development

  Xu, Xiaoming

• Formulation Considerations for In Vitro Characterization Based Approaches of Locally Acting Complex Generic Drug Products

  Kozak, Darby

• Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness

  Kozak, Darby

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  Kozak, Darby

• In Vitro Bioequivalence Testing for Topical Ophthalmic Suspension Products

  Kozak, Darby

• Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use

  Jones, A; Chung, HS; Kozak, D

• An Overview of Challenges and Opportunities for Innovation in Complex Generic Drug Product Development

  Jiang, Xiaohui