martes, 19 de septiembre de 2017

New info available: Upcoming FDA public workshops on complex generic drug products



In October 2017, the Food and Drug Administration (FDA) is hosting three public workshops on complex generic drug products. Agendas, speaker information, registration, and other details have been added to the meeting web pages. Please visit the individual meeting web pages listed below to learn more.

This workshop is intended 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, and 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 new analytical methods and innovative in vitro testing methodologies that support establishment of equivalence of complex generic drug products and facilitate the regulatory review process.  

This workshop will provide an overview of current regulatory science initiatives concerning generic topical dermatological drug products and is intended to engages stakeholders on alternative approaches to evaluate bioequivalence for topical dermatological generic drug products that could be more efficient, more sensitive and reproducible.

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.

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