Scopes Trial

On 2nd May 2016, the drug safety podcast of FDA made an announcement of a change in the brand name of anti-depressant drug Brintellix, so that it is not mistaken for anti-platelet drug Brilinta. The podcast was announced by Advanced Practice Nurse, Lesley Navin. She mentioned that the FDA aims to minimize prescription errors caused by similarity in the two drug brand names. Brintellix, manufactured by Takeda Pharmaceuticals will be renamed to Trintellix, beginning June 2016. Ms. Navin further…

The death of Socrates was controversial even before it happened- the most well-known and widely read account on the subject is from Socrates himself, reported through Plato’s narration. The circumstances of the execution are contested not only in terms of determining historicity or discerning the historical fact, but also the manner of interpreting the content itself. Whether the death was a suicide, using the legal system as a noose instead of being found guilty and convicted; to what extent…

The drug companies’ journey to search for a drug to cure Female Sexual Dysfunction started after the development of Viagra for men. The drug companies were not even aware of sexual dysfunction for females until this point. Despite not knowing whether FSD was a real disease, drug companies started developing a “cure” for this new phenomenon. The documentary had various sex experts and medical professionals describing the processes of developing drugs. There needs to be an actual disease before…

them to select from options that already exist. The agency did not think about what the next step after accomplishing the creation of the drug and the approval of the FDA. Doug Reynolds and Becky teamed up because of her mastery in leading clinical trials and reacting to FDA request (Johnston, and Marshall, 2009), needed to move rapidly in making a sales…

Particular scholars have proposed prisoners should be the target group for researchers to enroll in human clinical trials. Using prisoners has the potential to be a more efficient way of conducting clinical trials versus using only volunteers to research and develop useful drugs or treatments. One explanation for this is that conducting efforts to recruit volunteers, screening them, determining if they are healthy enough to continue through the entire research study, and having a readily…

As the use of placebos increases, so does the debate over the ethicality of switching oblivious patients’ medications with placebos. A wide variety of doctors believe the switch is completely ethical and helpful, especially when confronting the opioid epidemic, while others claim “it is unethical to deceive patients by prescribing fake treatments,” (Marchant) especially when it can negatively impact a doctor-patient relationship if the patient is unaware. When my mother’s friend a simple,…

Clinical Trial Team Structure Strategies Demands of industry and regulators for an improved clinical research landscape include quality by design concepts and increased efficiencies. Teams developing clinical research trials must be strategic to meet these demands and discover future innovations. Team structure must adapt to successfully implement a risk-based approach to trial execution. Team structures should become flexible and collaborative. Additional roles must be included on a…

First CLAS Standard selected: Which standard have you selected? What is the definition of the standard in your own words? What is the purpose of the standard, what does it do, how does it promote culturally and linguistically appropriate services, etc.? The first standard I have chosen is providing effective, equitable, understandable and respectful quality care and services that are responsive to diverse cultural health beliefs and practices, preferred languages, health literacy and other…

manufacturing standards of the drug, there is also the general population healthcare requisite which needs to be met with the limited resources and technology available. For a new drug to reach the market, it takes more than a decade and several tests and trials that the FDA needs to clear. The information for the pre-clinical testing and the new molecular entity (NME) is submitted by a New Investigational Drug (IND) document to the FDA and if approved, it moves to the clinical phases. There…

Introduction Due to the complex nature of the needs of the elderly in the emergency room setting, there has been a movement to identify such high-risk patients through the initial triage in the emergency room. One such example is the Identification of Seniors At Risk (ISAR). The ISAR is used as a screening tool to expeditiously identify patients 65 years and older who are at risk for adverse outcomes while in emergency room setting as well as post–ED visit. The tool includes a six validated…