The topic for the paper is a description of a healthcare-related case history detailing both FDA and global
regulatory and healthcare agencies’ collaboration (WHO and EMA) in terms of:
Case management
Prevention and control of the infection/condition
Regulatory approvals(You can write down international regulation as well)
The paper should focus in detail on the regulatory aspects of the chosen case history in terms of development
of new diagnostic tests, vaccines or therapies to combat and treat the disease/condition, clinical trials
conducted (if any), and subsequent FDA and EMA approvals.
-APA format
-Times New Roman, font 12
please also refer to the websites/documents listed below as background information for the paper.
https://www.who.int/about https://www.who.int/health-topics/
https://www.who.int/emergencies/en/ https://www.fda.gov/medical-devices/medical-device-safety/emergencysituations-medical-devices
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization#abouteuas
https://www.ema.europa.eu/en/authorisation-procedures
https://www.sciencedirect.com/science/article/pii/S2452302X16300638