lunes, 18 de septiembre de 2017

FDA Announces a Public Workshop on Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review




FDA Announces a Public Workshop on Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review 

The U.S. Food and Drug Administration (FDA) would like to extend an invitation to attend a two-day public workshop titled “Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review.” The purpose of this workshop is to: 
  • 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. 
  • 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 information gained through the workshop will 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.

The date, time, and location of the workshop are as follows:

Date: October 2-3, 2017
Time: 8:30 a.m. to 4:30 p.m. (both days) 
Location: Building 31, Room 1503 (Great Room), FDA White Oak, 10903 New Hampshire Avenue, Silver Spring, MD 20993

Registration is free and can be accessed at Registration Form. You may register by September 25, 2017 to attend at FDA White Oak or via Webcast. 

For more information, including the final agenda and how to attend in-person or via webcast, please visit our website at https://www.fda.gov/Drugs/NewsEvents/ucm554182.htm.

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