Option 1: Per the FDA’s website (https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization): “The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.” Three examples of the FDA’s response to the COVID-19 public health emergency were issued in March 2020: “Process for Making Available Guidance Documents Related to Coronavirus Disease 2019 allows the Agency to rapidly disseminate essential Agency recommendations and policies related to COVID–19 to industry, FDA staff, and other stakeholders” Guidance document “Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” Guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency.” Summarize section 564 and how it applies to the COVID-19 pandemic. Review the example guidance documents and explain how they accomplish the goal of emergency management in the areas they address (ventilators and clinical trials). Midterm Paper Standards for Evaluation: Regardless of your selection, I will evaluate your paper on the following criteria: Quality of research: The completeness of your examination of relevant sources (regulations, case law, medical/pharmacology journals, news media) and the extent to which you have uncovered and documented the information necessary to cover the topic in-depth. Quality of Presentation: The extent to which the paper’s organizational structure and writing style convey the paper’s thesis to the intended audience. The length of the paper is 10 pages., not 5. Grammar, syntax, etc. The relative weight assigned to each criterion is the following: Quality of research (thoroughness and depth of understanding): 70% Quality of Presentation: 20% Grammar, etc.: 10%
