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(115)
• Posters(49)
• Presentations(26)
• Papers(40)

• Bioequivalence Assessment for Complex Ophthalmic Products

  Urtti, Arto

• Physiologically-based Pharmacokinetic Modeling to Support Generic Ophthalmic Product Development and Regulatory Decision Making

  Tan, Mingliang

• Intravitreal Sustained Release Ganciclovir: An Orphan Generic

  Smith, Thomas

• Comparing Device User Interfaces and Seeking Advice in the Pre-ANDA Period

  Hartka, Kathryn

• In vitro and in vivo characterization of ophthalmic suspensions

  Sailor, M

• Regulatory Uses of IVRT Studies on Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products

  Qin, Bin

• 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

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

  Kozak, Darby

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

  Xu, Xiaoming

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

  Kozak, Darby