Scenario:An NDA is submitted for a novel drug to treat severe, treatment-resistant systemic lupus erythematosus (SLE). The clinical safety review reveals a  risk of severe, reversible neutropenia (a drop in white blood cells), but the drug achieves clinical remission in  of patients who have failed all other therapies. Question:Applying the core regulatory mandate of the Office of New Drugs (OND), how will the review team approach this approval decision?

Scenario:A pharmaceutical sales representative distributes a brochure to clinical specialists claiming that a newly approved drug is “the ultimate and safest breakthrough therapy for rheumatoid arthritis,” but fails to mention a prominent Boxed Warning regarding severe, opportunistic infections that is featured on the FDA-approved professional labeling. Question:Which FDA division is responsible for addressing this promotional violation, and what is the typical regulatory action taken?

Scenario:The FDA grants “Accelerated Approval” to an oncology drug based on a surrogate endpoint (tumor shrinkage) that is reasonably likely to predict a clinical benefit (increased overall survival). Question:What is the primary regulatory condition and post-marketing safety obligation associated with an Accelerated Approval?

Which of the following explains why the bottom of this pot was broken deliberately?

Choose two of the prompts listed above, and provide a response to them. Cut and paste the full question you are answering before writing your reply. 

What term describes the suggestion that successful leadership requires matching leaders with primarily stable leadership styles to the demands of the situation?

What term describes a theory that recognizes the importance of goals in improving employee performance?

Short Essay Question Instructions: Below you will find 3 short essay questions chosen at random. Choose two (and only two) of the questions to respond to in the text area below.  Each short essay should be around the length of a medium-length paragraph (approx. 200-250 words). Do not write more than 300 words per answer.  Type the full question before you begin writing so that I know which question you are answering. (You may be able to cut and paste, but this function is likely disabled.)  Your response will be worth up to 10 points (5 points per question).

What term describes employee organizations that work with employers to achieve better pay, hours, and working conditions?

What is the theory that states that employees learn not only through direct experience but also through observation and personal qualities?