Development and Regulation of Medical Countermeasures for COVID-19 (Vaccines, Diagnostics, and Treatments): Frequently Asked Questions [June 25, 2020] [open pdf - 1MB]
From the Summary: "In recent months, the Coronavirus Disease 2019 (COVID-19) pandemic has spread globally, with the United States now reporting the highest number of cases of any country in the world. Currently, there are few treatment options available to lessen the health impact of the disease and no vaccines or other prophylactic treatments to curb the spread of the virus. [...] This report answers frequently asked questions about current efforts related to research and development of medical countermeasures, their regulation, and related policy issues. Although several efforts are underway, medical product research, development, and approval is a difficult and high-risk endeavor that takes years in typical circumstances. In response to COVID-19, this process has been expedited, including through several federal programs and mechanisms covered in this report. However, expedited medical product development can carry certain risks, such as a more limited safety profile for new products upon approval."
CRS Report for Congress, R46427
Congressional Research Service: https://crsreports.congress.gov/