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  1. News & Events for Human Drugs

Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review; Public Workshop, October 2 - 3, 2017


The Food and Drug Administration is announcing a public workshop entitled “Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review.” The workshop is free to attend and open to the public--register online disclaimer iconnow!

Modeling and simulation have been increasingly used in drug development, providing a framework for synthesizing information and extrapolating beyond what has been studied. Model-informed drug development (MIDD) approaches can be applied to both brand and generic drug products. MIDD includes pharmacokinetic/pharmacodynamics (PK/PD) models, physiologically-based pharmacokinetic (PBPK) or absorption models, systems pharmacology, quantitative risk modeling, and emergent machine learning tools. These application areas can leverage the large pharmaceutical data sets (big data) available to the FDA and other organizations to improve development and regulatory decision making. Quantitative approaches have been used to address critical scientific and regulatory issues in all phases of the product lifecycle: from pre-investigational new drug applications (INDs) through NDAs, ANDAs, and post-approval evaluation of new and generic drugs. Given the broad applications of modeling and simulation through the entire lifecycle of a product, there is a need to identify best practices to improve the routine use and acceptance of modeling and simulation for regulatory decision making for generic drugs.

The purposes of the workshop are to:  

  1. Engage global stakeholders and share experience and vision on using quantitative approaches in regulatory decision making for generic drug development and product lifecycle management;
  2. Identify and prioritize potential areas for global harmonization for tools to inform regulatory decision making;
  3. Share the current state of knowledge and practice in utilizing quantitative methods and modeling for generic drug development and review by case demonstrations and by integrating experience and lessons learned from new drug development and reviews;
  4. Identify opportunities for complex and locally acting product development and discuss approaches and principles in using quantitative methods and modeling to aid product-specific guidance development, pre-ANDA interactions between FDA and prospective applicants, ANDA reviews, and postmarket performance monitoring; and 
  5. Discuss next generation quantitative method and modeling toolsets, future directions, and application areas.

Dates & Times:          October 2 (8 a.m. - 4:30 p.m.)

                                    October  3, 2017 (8 a.m. - 4:00 p.m.)

   FDA White Oak Campus
                    10903 New Hampshire Avenue
                    Bldg. 31 Conference Center
                    Section B and C of the 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.

Registration: You may attend in person or via the Webcast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. Please register by  To Register, go to: Quantitative Methods and Modeling Workshop Registration disclaimer icon on or before September 25, 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/dqmm1017/. Please log-in as guests.

Meeting Materials: Agenda (PDF - 65 KB)

Remarks by Scott Gottlieb, M.D.

Comments:  Will be added once FR notice is posted and docket is created.

For Further Information Contact:

Lanyan (Lucy) Fang Ph.D. or Liang Zhao Ph.D.,
CDER Office of Generic Drugs, Division of Quantitative Methods and Modeling
Email: [email protected]

Meeting Recordings 

Day 1:

Day 2:

Meeting Presentations

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