ritten ASSigillleft ff1. Alldlysis 01 salidoz's willitrope - rollflat. WOTW/PDF Lenigul. 10 III 2 pages (single spaced). Students are to: research the approval of Sandoz's Omnitrope Develop a familiarity with the CDER and CBER websites Research FDA's approval of Omnitrope and summarize the elements below. Identify the product by both trade and brand name as well as the product's sponsor . Identify dates of critical regulatory milestones for the product (including NDA or BLA a date) o Provide a detailed description of the product (as available from public sources), i its molecular mechanism(s) of action and specific indications for use . Describe what preclinical safety data was likely submitted to CBER (or CDER) in suppo sponsor's IND and BLA or NDA applications o Describe what the Sponsor's IND clinica investigational plan likely contained; . Identify the class/type of product and explain why the product is regulated by either FDA Center for Drug Evaluation and Research (CDER) or FDA's Center for Biologics Evaluat Research (CBER) Answer the following question: why was Omnitrope approved under the FD&C Act and Public Health Service Act? Expectations: Students will be expected to describe all elements above in citing pertinent regula