New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products
January 9, 2018 (8:30 a.m. – 4:30 p.m.), FDA White Oak Campus
The workshop is free to attend and open to the public.
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Since its commencement in 2012, the Generic Drug User Fee Amendments (GDUFA) Regulatory Science Research Program has aided our understanding about the critical product attributes that are relevant for in vivo performance of Orally Inhaled and Nasal Drug Products (OINDPs), and has led to the development of tools beneficial to both industry and the FDA for developing and assessing generic OINDPs. Several external and internal research projects have been initiated under the GDUFA Regulatory Science Research Program. The outcomes from these research studies have provided valuable insights about the factors that influence the performance of OINDPs. The focus of this FDA Workshop is on the evaluation of these new methods for characterizing and demonstrating equivalence of OINDPs, including discussing the areas in which these methods may significantly contribute to generic product development and regulatory understanding, how and under what conditions the methods should be conducted and evaluated, and inherent scientific challenges with this complex class of products.
The purposes of the workshop are to:
- present the outcomes from the research projects initiated under the GDUFA Regulatory Science Research Program;
- discuss how regulatory science initiatives have helped address regulatory science knowledge gaps by providing insights on factors that influence the performance of generic OINDPs;
- share the Agency’s experience on the utility of novel analytical tools and methods developed under the regulatory science initiative for generic OINDP product development and bioequivalence assessments; and
- obtain input from the public on what, when, where, and how analytical methods and procedures should be applied in the development and review of abbreviated new drug applications (ANDAs) for complex OINDPs.
To register, go to: Generic Orally Inhaled and Nasal Drug Products Workshop Registration on or before Dec 30, 2017. Registration on the day of the public workshop will be provided on a space available basis beginning at 7:30 a.m. Webcast Link for Online Attendees: https://collaboration.fda.gov/r19djs3yfsf/ . Please log-in as guests.
Date:
January 9, 2018
Time:
8:30am - 4:30pm
Location:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31 Conference Center
Great Room (Rm. 1503)
Silver Spring, MD 20993
Public Meetings at FDA White Oak Campus
Visitors attending public meetings in the Building 31 Great Room must enter through Building 1, where they will undergo the routine security check procedures for building entry. A visitor badge and escort are not required to attend a public meeting in the Great Room. Please allocate 15 - 30 min for arrival and security checks. Driving and parking information for visitors to the FDA, along with a campus map, can be found at: FDA White Oak Campus Visitor Information
Meeting Materials
- Meeting Agenda (PDF - 29 KB)
- Federal Register Notice
Presentations:
Introduction
Session 1: Predictive Dissolution Methods for OINDPs
- Part 1: https://collaboration.fda.gov/p4x8n2ijonv/
- Part 2: https://collaboration.fda.gov/p14roiezol5/ (Includes panel discussion)
Session 2: Novel Analytical Tools for Characterization of Nasal Suspensions
Session 3: Realistic Models for Prediction of Regional Drug Deposition from OINDPs
Session 4: Computational Models to Understand In Vivo Performance of OINDPs
Panel Discussion: Future Direction of Generic OINDP Regulatory Science Research
Additional details will be posted as they are available. Please check the Federal Register and this website in the coming weeks. FOR FURTHER INFORMATION CONTACT: Renishkumar Delvadia, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, rm. 4704, Silver Spring, MD 20993, 240-402-7979, email: Renishkumar.Delvadia@fda.hhs.gov