| FDA Adds Content About Medical Products Authorized for Emergency Use to its Guidance on Clinical Trials of Medical Products During COVID-19 The U.S. Food and Drug Administration has added content to the question-and-answer appendix in its guidance titled "Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency." The updated guidance includes a new question-and-answer regarding whether FDA considers receipt of medical products authorized under an emergency use authorization for use in clinical care, such as a vaccine to prevent COVID-19 or a monoclonal antibody to treat COVID-19, to be receipt of "investigational" medical products. This information may be relevant when sponsors are considering eligibility criteria that exclude patients from enrolling in clinical trials if they have received certain medical products. FDA issued this guidance on March 18, 2020, recognizing that the COVID-19 public health emergency may impact the conduct of clinical trials of medical products, including drugs, devices, and biologics. Challenges in conducting clinical trials may arise from isolation practices, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or clinical trial participants become infected with COVID-19. | 
No comments:
Post a Comment