domingo, 20 de agosto de 2017

Save the Date! Upcoming FDA public workshops on complex generic drug products

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)
In October 2017, the Food and Drug Administration (FDA) is hosting three public workshops on complex generic drug products.

This 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. 

This workshop is intended to engage stakeholders in a discussion about the use of in vitro testing to demonstrate bioequivalence of complex generic drug products.

This workshop will provide a platform for discussion of current barriers in the development of topical dermatological generic drug products. The public workshop will also focus on ways to improve patient access to these products.

The workshops will be held on FDA’s main campus in Silver Spring, Maryland and will be webcast for those who cannot attend in person. Further information will be posted to the meeting-specific webpages as it becomes available.

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