Review and Evaluation of the FDA Reports and Findings for the Clinical Trial Studies

This next major assignment requires you to investigate and research two very important components of the overall Johnson and Johnson – Basilea case study. The first component of your research is to fully understand what the major issues were in the FDA evaluation of the clinical trials associated with Ceftobiprole. Secondly, you are to investigate other antibiotics that have been reviewed within the guidelines of the FDA. In this paper, you will integrate these two components in order to develop a well crafted 5-7 page paper that allows you to 1) develop your assessment of the most significant issues (as reported); 2) link these issues to course material and other studies that have been evaluated by the FDA; 3) in order to develop a recommendation that simply identifies the 4-5 most important aspects of the clinical studies that can been addressed through improved monitoring activities. As part of this section, you will identify the issue and develop a well-crafted and detailed set of recommendations to improve the trial management activities.CLICK HERE TO GET MORE.........