Documents PPT Nsofor Working Proactively to Mitigate Risk

PPT Nsofor Working Proactively to Mitigate Risk

Technology FDA Expectations for Traceability in Device & Diagnostic Design

1. FDA Expectations for in Device & Diagnostic DesignJohn AvellanetCerulean Associates LLCwww.CeruleanLLC.com© Cerulean Associates LLC all rights reserved…

Education Abriviated new drug application

1. Pool of topics:1.Introduction2.History of ANDA3.Guidelines available for ANDA4.Filling of ANDA5.Manufacturing and control requirements of the ANDA6.180 days exclusitivity…