Find the presentations below on an archived version of this webpage 

• FY 2014 Regulatory Science Initiatives Part 15 Public Meeting
• GDUFA Regulatory Science Update
• FY 2015 Regulatory Science Priorities
• Tackling Generic Drug Safety
• €œManagement of Device Changes Through the Product Lifecycle
• Why Clinically Appropriate In Vitro Inhaler Testing? – Introducing the Patient Experience into the Picture
• €œResearch Opportunities in Evaluating Abuse Deterrent Opioid Formulations
• €œImpact of Formulation and Process Variations on the Quality of Freeze Dried Products: How do we identify, control, and characterize critical variations?
• Raw Material and Manufacturing Factors Affecting the Quality of Generic Pharmaceutical Products
• Expanding BCS-Based Biowaivers
• The New Science of (Oral) Bioequivalence: In Vivo Predictive Dissolution (IPD)
• Biopharmaceutics Risk of Orally-Administered Products
• Direct Measurement and Computational Modeling of In Vivo Drug Dissolution in Human GI tract for Accurate BA/BE Study and Prediction of Generic Drugs
• Use of Microdialysis for the Evaluation of Topical Bioequivalence
• Non-Clinical Tools for Performance Testing of Complex Drug Products
• Challenges for Non-Biological Complex Drugs (NBCDs)
• €œApproval Standards of Follow-on Versions of IV Nanocolloidal Iron-based Medicinal Products (NBCDs)
• Nanosimilars
• €œA NanoSensor for Detecting PPB Levels of OverSulfated Chondroitin Sulfate in Unfractionated Heparin
• Importance of Regulatory Research Funding for Long Acting Release (LAR) Drug Products
• €œIntravitreal Sustained Release Ganciclovir: An Orphan Generic
• Developing, Implementing, and Validating Reliable Methods for BU Testing