U.S. Food and Drug Administration at AAPS 2026 PharmSci 360
Oct 25–28, 2026 New Orleans, LA ~4k attendees Website
U.S. Food and Drug Administration brings 27 presentations to AAPS 2026 PharmSci 360 in New Orleans. Its program centres on generic drug review, with bioequivalence approaches built on modeling how drugs are absorbed and distributed in the body. Its sessions range from long-acting injectables and topical products to immunogenicity testing for new modalities and lipid nanoparticle delivery of RNA.
| Organization | AAPS 2026 PharmSci 360 Attendance |
|---|---|
U.S. Food and Drug Administration Silver Spring, MD | |
US federal agency that regulates drugs, biologics, medical devices and food, including review and approval of new and generic medicines. | Talk Mon Oct 26 9:00am–9:30am Talk Mon Oct 26 9:30am–10:00am Poster Mon Oct 26 9:30am–10:30am Regulatory Framework for Cross-Referencing Bioequivalence Studies Between Abbreviated New Drug Application Submissions: An Analysis of Permissible Cases Talk Mon Oct 26 10:30am–11:00am Poster Mon Oct 26 11:30am–12:30pm Tlag Issues Observed in Bioequivalence Studies Under Fed Condition for Lamotrigine Extended- Release Tablets: Potential Association with Formulation and In Vitro Dissolution Talk Mon Oct 26 1:30pm–2:30pm Poster Mon Oct 26 2:30pm–3:30pm Investigation of Product Manipulation Methods and Common Deficiencies in In Vivo Pharmacokinetic Studies of Generic Abuse-Deterrent Formulations: A Retrospective Regulatory Analysis Poster Mon Oct 26 2:30pm–3:30pm Physiologically-Based Pharmacokinetic/Pharmacodynamic Modeling to Explore In Vitro Bioequivalence Approach for Brinzolamide Ophthalmic Suspensions Poster Mon Oct 26 2:30pm–3:30pm Solubility, Dissolution, and PBPK-Based Safe Space Analysis for BCS Class III Biowaiver Assessment of Selected Drug Substances Poster Mon Oct 26 3:30pm–4:30pm Using PBPK Modeling and Simulations to Support Alternative BE Approaches for Olaparib Generic Drug Products Poster Tue Oct 27 9:30am–10:30am A Survey of Case Studies for the Removal of Bioequivalence Study Data due to Low Exposure Using Scientific Principles Introduced in the ICH M13A Guidance Talk Tue Oct 27 9:30am–10:00am Poster Tue Oct 27 9:30am–10:30am Physiologically Based Pharmacokinetic Modeling to Support Bioequivalence and Approval of a Generic Tazarotene Topical Cream in Lieu of a Pivotal IVPT Bioequivalence Study Talk Tue Oct 27 10:30am–11:00am Poster Tue Oct 27 10:30am–11:30am Mechanistic Modeling Assessing the Impact of Drug Product Characteristics on In Vivo Performance of Topical Products - A Case Study with Diclofenac Sodium Topical Gel Poster Tue Oct 27 12:30pm–1:30pm Insights into Bioequivalence Bridging Strategies for Pre and Post-Approval Changes in Generic Topical Drug Products Poster Tue Oct 27 12:30pm–1:30pm Physiologically Based Pharmacokinetic/Biopharmaceutics Modeling in ANDA Submissions: A Retrospective Analysis of FDA Regulatory Experience and Outcomes Talk Tue Oct 27 1:30pm–2:30pm Talk Tue Oct 27 1:30pm–2:30pm Talk Tue Oct 27 1:30pm–2:30pm Poster Tue Oct 27 2:30pm–3:30pm Chromatographic Related Bioanalytical Deficiencies in Sample Reanalysis, Reinjection, and Reintegration during Bioequivalence Assessment Talk Tue Oct 27 3:15pm–3:30pm Learning From the Future: Towards Continuous Manufacturing of Nanomaterials Manufacturing and analytical characterization Poster Wed Oct 28 9:30am–10:30am Incorporation of FDA's Artificial Intelligent (AI) Tool into Pediatric Excipient Assessment for Abbreviated New Drug Applications (ANDAs) Session Wed Oct 28 10:00am–11:00am Hot Topic: Are Regulators on the Same Page for Pediatric Drug Data? Talk Wed Oct 28 10:40am–11:00am Poster Wed Oct 28 11:30am–12:30pm In Vivo Abuse-Deterrent Formulation Pharmacokinetic (In Vivo ADF PK) Studies for Generic Opioid Drug Products: Scientific Considerations and Best Practices for Study Design and Conduct |
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