To give students an opportunity to increase their familiarity with the processes associated with seeking FDA regulatory approval to market biologics products

I have found a biologic approved in 2012, called Bivigam. It is an infusion of immune globulin (human). Please see below the following links, they have all the information regarding the biologic.

• Identify the product by both Trade and Brand name as well as the product’s sponsor
• Describe the reason for your Group’s interest in the product
• Identify dates of critical regulatory milestones for the product (including BLA
approval date)
• Provide a detailed description of the product (as available from public sources),
including its molecular mechanism(s) of action and specific indications for use
• Identify the class/type of product and explain why the product is regulated by
CBER© 2014-2015 Northeastern University: College of Professional Studies 5
• Identify the general and product-specific FDA guidance documents that apply to the product and the premarket submission, as applicable
• Describe what preclinical safety data was likely submitted to CBER in support of
the sponsor’s IND and BLA applications
• Describe what the Sponsor’s IND clinical and investigational plan likely contained

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