Drugs

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

Summary:

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 intended to (1) engage stakeholders in a discussion of current and emerging scientific approaches and applications for the conduct of quantitative modeling and simulations in generic drug development, especially for complex and locally acting products, and (2) gain inputs regarding opportunities and knowledge gaps related to the use of quantitative modeling and simulation to inform regulatory decision making through the product lifecycle.  The FDA will use the information gained through the workshop to support product-specific guidance development, improve pre-ANDA interactions with applicants, increase the quality and efficiency of regulatory reviews, and identify a next generation modeling and simulation toolset for complex and locally acting products.

Date:           October 2 - 3, 2017

Time:           8:30 a.m to 4:30 p.m.

Location:    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 

Registration Form: 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 September 1, 2017.

Webcast Information

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: CDER-OGD-OfficeofResearchandStandardsAnnouncement@fda.hhs.gov

Meeting Materials: Will be added once available.

Presentations: Will be added once available.

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Page Last Updated: 07/10/2017
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