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Form BD15 DOC

Form BD15 DOC

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but went on and I am the regulatory project manager in the division of anesthesia analgesia and addiction products and I have a hard job today to keep you all awake after the lunch so let's see what how it goes the topic is components of new drug application and biologics license application it's in two part I'm going to talk more about the content and format of the application what what should be in the application and my colleague Lois tree is going to talk talk more about the review process of the application so as far as the learning objectives are concerned we will look at the application approval pathways various through which application can get approval we will look into the content and format of an application and lastly but not the least we will look into the forms and documentation --zz that are required and we are going to focus on module 1 of the CTD module and look at some examples and best on best practices so just before we go into what should be

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