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Hello! I am assuming that your biological product is in Phase I with my response below. However, if you are further along in development, then phase appropriate stability data should be presented. The guidance doc titled, "Content and Format of Investigational New Drug Applications (INDs) for Phase1 ...

Hi Elisa: Completely agree with Susan! The US FDA website is a great resource for free webinars and information and you will get a lot out of it. There are a few organizations which offer paid CMC training sessions and these include: DIA (Drug Information Association), CfPA (Center for Professional ...

Hi Gene: Jessica Kokosinski from G&L Scientific responding to your question. My Regulatory Affairs background is primarily in Biologics CMC (monoclonals, vaccines, blood products, and some cellular therapy products). Please note that my thoughts on your question are shrouded in assumptions and, ...