Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Multiple Choice Identify the choice that best completes the statement or answers the question. The nurse has provided a presentation to middle school children about nursing as a career. One 1. of the children stated that he wanted to be a pediatric nurse, because he wants to take care of babies and little “kids.” What would be an appropriate response to this middle school –aged child? 1. “Nursing is a general practice; all nurses must know how to take care of all ages of patients.” 2. “As a pediatric nurse, you would get to care for babies and little kids as well as children through their teenage years.” 3. “What you are describing is actually a neonatal nurse. Neonatal nurses work with newborn babies, toddlers, and preschool -age children.” 4. “Being a pediatric nurse requires a master’s degree, so be sure to work hard in school!” The medical -surgical float nurse is assigned to the pediatric unit for the first time and states that 2. the skills are “the same as general nursing since children are little adults with smaller bodies.” What component of pediatric nursing contraindicates this statement? 1. Pediatric nursing involves care based on the developmental level of the patient. 2. Pediatric nursing involves the patient’s family in the plan of care. 3. Pediatric nursing in based on prevention of infectious diseases. 4. Pediatric nursing involves cultural sensitivity in patient care. The culturally sensitive pediatric nurse is aware of the racial makeup of the U.S. population. Which of the following reflects the demographics of the U.S. pediatric population in 2018, based 3. on U.S. Census Bureau data? 1. The American Indian and Alaska Native population represent one -fifth of the pediatric population. 2. About half of the children fall in the category of something other than White non- Hispanic. 3. The population of Asian children decreased from 2015 to 2018. 4. There was no change in the population of Non -Hispanic children who represent two or more races between 2015 and 2018. The nurse at a family clinic is providing care to an adolescent patient diagnosed with diabetes. The patient has verbalized discomfort with the feelings of isolation when unable to drink alcohol with their friends. Which of the following would be the most appropriate response to this statement? 4. 1. “Drinking alcohol is not only illegal but dangerous for your blood sugar control and overall well-being.” 2. “You can still drink alcohol, in moderation, if you control the sugar spike with more insulin.” 3. “Prepare for alcohol intake with more water and less carbohydrates before drinking to slow sugar spikes.” Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. 4. “It is understandable that you want to be included, but perhaps we can work out a plan on how to work through those situations.” Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Which statement best describes the common core concepts of the different models of pediatric 5. nursing? 1. All models focus on the open communication between the child and nurse. 2. All models focus on importance of family relationship to the child. 3. All models focus on safeguarding the child’s dignity during care. 4. All models focus on coordination of care needs that arise during illness. Which of the following tasks is associated with the pediatric medical home care model of pediatric nursing? 6. 1. The nurse refers the family to a childhood cancer support group prior to discharge from the hospital. 2. The nurse includes a simple explanation of the procedure to the child based on the child’s developmental level. 3. The nurse includes the family’s cultural celebrations and observations while providing care to the child. 4. The nurse develops the plan of care with the child and family as the focal point of the interventions. The pediatric nurse begins a research project on 8-year-old patients with the medical diagnosis of pediatric acute -onset neuropsychiatric syndrome (PANS). The family has consented to the research, but as the nurse begins to administer the intervention, the patient refuses to cooperate. 7. What is the appropriate response to this refusal? 1. The nurse should discuss with the family the options of performing the intervention without the child’s knowledge. 2. The nurse should explain to the child that this is necessary and promise a reward at the end of the research project. 3. The nurse should refuse to perform the intervention until the child consents to the intervention and project. 4. The nurse should discuss the pros and cons of the research project with the child and focus on the outcomes. A nurse is providing relationship -based care to a pediatric patient. Which of the following is a challenge the nurse is likely to encounter while using this model of care? 1. Maintaining a sterile field for a procedure with a restless toddler 2. Communicating with the blended family on regular basis 8. 3. Treating children with antibiotic -resistant illnesses 4. Caring for a larger number of children with autism spectrum disorders and childhood depression The pediatric nurse desires to expand his or her career options to become the hospital’s nurse educator of pediatrics. Which of the following is necessary for this nurse to achieve this career goal? 1. The nurse is recommended to earn a minimum of a master’s degree in nursing. 2. The nurse must earn a minimum of a doctorate degree in nursing. 9. 3. The nurse must implement and develop research in nursing practice. 4. The nurse must implement a plan to obtain certification in pediatrics. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing. Post-Marketing Surveillance : Even after approval, drugs continue to be monitored for long -term safety and effectiveness through post -marketing surveillance (Phase IV studies). This helps identify any rare or long -term adverse effects that may not have been detected in clinical trials. Regulatory Approval : After successful completion of clinical trials, the drug manufacturer submits a New Drug Application (NDA) to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory body reviews the data and decides whether to approve the drug for marketing.
