Development and Regulation of Medical Countermeasures for COVID-19 (Vaccines, Diagnostics, and Treatments): Frequently Asked Questions | NLM

Disaster Information Management Research Center | NLM

Development and Regulation of Medical Countermeasures for COVID-19 (Vaccines, Diagnostics, and Treatments): Frequently Asked Questions

06/25/2020 12:00 AM EDT

Source: Congressional Research Service [Library of Congress] (CRS). Published: 6/25/2020. This 33-page 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. (PDF)