New York University Operational Considerations Essay

Assignment: Based on the information provided below and discussed in class, prepare a 3 – 4 page report outlining recommendations for preparation and maintenance of an Investigational New Drug (IND) application. Background Information: Submission of an initial IND and ongoing IND maintenance, perhaps more so than most activities in drug development, require a high level […]

New York University Cotellic Essay

Assignment: Cobimetinib (Cotellic) is an inhibitor of the mitogen-activated protein kinase (MAPK)/extracellular signal regulated kinase 1 (MEK1) and MEK2. These proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. BRAF is a member of the Raf kinase family of growth signal transduction protein kinases. This protein plays a role […]

New York University Specific Public Health Policy NY A02883 Narrative Essay

IMPORTANT NOTE REGARDING WORD LIMIT REQUIREMENTS: Please note that each and every assignment has its own word limit. Identify a specific public health policy at the state level. Federal policies such as the Affordable Care Act, Medicare, or Social Security, etc. are not appropriate for this assignment. You can find state-level policies by visiting the […]

PUB 620 New York University Benchmark Final Project Paper

IMPORTANT NOTE REGARDING WORD LIMIT REQUIREMENTS: Please note that each and every assignment has its own word limit. For your final project, review the feedback provided by your instructor and make revisions accordingly. Integrate the specified aspects from your previous assignments, as directed, to develop your final Program and Planning Project assignment. Use the guidelines […]

New York University New Drug Application Paper

Based on the information provided below and discussed in class, prepare a 3 – 4 page report outlining recommendations for preparation, submission, and maintenance of a New Drug Application (NDA). Background Information: The NDA is the vehicle Sponsors use to propose the FDA approve a drug for sale in the United States, and the goals […]

New York University Letter to FDA Commissioner Regarding PDUFA Essay

It is 2021 and the United States Congress will soon convene to discuss PDUFA reauthorization. During this time the Commissioner of the FDA will go before members of Congress to explain how it can help the Agency to continue fulfilling its mission. Assuming the FDA has properly met its review timelines while collecting user fees […]

New York University Global and Public Health Essay

IMPORTANT NOTE REGARDING WORD LIMIT REQUIREMENTS: Please note that each and every assignment has its own word limit. Defining international or global health is important and some consider global health synonymous with public health. Select one of the following two statements: 1. Global health is public health requiring similar training and research methods. 2. Global […]

New York University Safety Information in Drug Approval Paper

In completing Writing Assignment students will have the opportunity to: Demonstrate an understanding of the basic principles of what encompasses safety science with respect to drug/biologics development Demonstrate an ability to extract and interpret safety-relevant information form the publicly available FDA Drug Approval Package Information Demonstrate an ability to describe/analyze safety information for an approved […]

PUB 660 New York University Wk 4 Blazing Brush Forest Fire Visual Presentation Task

IMPORTANT NOTE REGARDING WORD LIMIT REQUIREMENTS: Please note that each and every assignment has its own word limit. This is a Collaborative Learning Community (CLC) assignment. The purpose of this assignment is to collaborate with your team to formulate a crisis management plan. Throughout Weeks 1-4 of the course, you will participate in a series […]

New York University Wk 7 Environmental Injustice Failure in Flint Case Study

IMPORTANT NOTE REGARDING WORD LIMIT REQUIREMENTS: Please note that each and every assignment has its own word limit. An important aspect of leadership is understanding how to tailor communication based upon the recipient of the message. Thinking about the “A Case Study of Environmental Injustice: The Failure in Flint” topic material, discuss how the public […]