Kindly explain in details the following about Omnitrope –
Describe what the Sponsor’s IND clinical and investigational plan likely contained for Omnitrope drug by Sandof
Identify the class/type of Omnitrope drug
Explain why Omnitrope is regulated by either FDA’s Center for Drug Evaluation and Research (CDER) or FDA’s Center for Biologics Evaluation and Research (CBER)
Explain in details – Why was Omnitrope approved under the FD&C Act and not the Public Health Service Act?