Discussion Prompt Question: Beth is a 46-year-old post-menop…

Discussion Prompt Question: Beth is a 46-year-old post-menopausal mentally disabled woman with LCIS, meaning, she is predisposed to develop breast cancer later in life. Her caregivers with power of attorney for health care decisions, bring her to the clinic for enrollment in a clinical trial, which is a randomized trial of tamoxifen v. raloxifene for the prevention of breast cancer in high-risk women. She fulfills all entry requirements but cannot consent due to her mental disability.  The caregivers must get review and approval from the FDA prior to enrolling Beth in the clinical trial.

Discussion Prompt Question: Corrective Actions and Preventat…

Discussion Prompt Question: Corrective Actions and Preventative Actions (CAPAs) are an important part of any cGMP design and focuses on the systematic investigation of root causes of issues in the manufacturing process.  Read the following Abbott Nutrition scenarios and match which type of ACTION that Abbott applied: (1) Corrective Action; or (2) Preventative Action

  Please select ALL correct answers. W.J. Hays’s Prairie Fir…

  Please select ALL correct answers. W.J. Hays’s Prairie Fire and Buffalo Stampede (1869) captures the closing of an era in the American West. By the 1880s, nearly 30-40 million buffalo had been slaughtered as a result of a complex series of developments, including: