The objective of this Assignment is to write about a current regulatory topic of

Assignment Description

The objective of this Assignment is to write about a current regulatory topic of interest – you may choose either a US-centric or globally oriented topic. Potential topics for the paper may include description of a case history or an ongoing topic of interest in healthcare that details international regulatory agency collaboration on a specific issue in regulatory affairs. You may choose FDA as one of the regulatory agencies in the international collaboration. The paper should also discuss in detail how these international regulatory agencies collaborated with each other as well as with the World Health Organization (WHO).
For instance, you may choose to discuss a healthcare related topic including, but not limited to the current COVID-19 pandemic, or the more recent Ebola virus outbreak, and discuss how the WHO collaborated with other global healthcare agencies on case management, prevention and control of the infection. In this scenario, the paper should detail how international regulatory agencies collaborated with each other as well as with WHO in the development of new diagnostic tests, vaccines or therapies to combat the disease/condition and help accelerate approvals for the same for quick patient access while ensuring they are safe and effective.
You may also choose to refer to but are not limited to the following websites/documents as background information for the paper.
 https://www.who.int/about
 https://ww w.who.int /health-topics/
 https://www.who.int/emergencies/en/
 https://www.fda. gov/medical-devices/medical-device-safety/emergency-situations-medical-devices
 https://www.ema.europa.eu/en/authorisation -procedures
 https://www.sciencedirect.com/science/article/pii/… 2302X 1 630 0638
 https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-useauthorization#abouteuas
Format of the Paper:
– 8 to 10 pages long submitted as a Word document (excluding bibliography, graphs, tables, and other visual images)
– Times New Roman font, size 12, single-spacing
– 1’’ margins
– Sub-headings may be used for clarity
– Accurate, complete, and properly formatted bibliography per APA -No Plagiarism

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