Describe what preclinical safety data was submitted to CBER or CDER in support of the sponsor’s IND and BLA or NDA applications for the drug approval process for Omnitrope which was approved under 505(b)(2). use in text references and provide reliable refereces at the end of the text using APA referencing
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Describe what preclinical safety data was submitted to CBER or CDER in support of the sponsor’s IND and BLA or NDA applications for the drug approval process for Omnitrope which was approved under 505(b)(2). use in text references and provide reliable refereces at the end of the text using APA referencing
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