Product Liability Update

As noted, here’s a brief update pertaining to the new and updated guidance for developers of therapeutics, vaccines, and tests for COVID-19. These guidance outline FDA’s vision of a forward-looking, and flexible approach to the evolving nature of the pandemic. In an update to its guidance on EUAs for COVID-19 vaccines, the FDA details the nonclinical, clinical and chemistry, manufacturing and controls (CMC) data needed to support an amendment to an EUA. According to the FDA, “[a]ssuming the prototype vaccine has been authorized under an EUA it is expected that the modified COVID-19 vaccine against a SARS-CoV-2 variant made by the same manufacturer and process as the prototype COVID-19 vaccine would be authorized through an EUA amendment to the EUA for the prototype COVID-19 vaccine,” For therapeutics, FDA has updated its existing guidance on developing drugs and biologics for COVID-19 and issued a new guidance specifically tailored to the development of monoclonal antibodies to address the emergence of variants. The guidance now includes an appendix on conducting drug resistance analysis, including recommendations for drug developers to continuously monitor for emerging SARS-CoV-2 variants. In FDA’s new guidance on developing monoclonal antibodies for COVID-19, FDA details the approaches to generating nonclinical, clinical and CMC data to support an EUA for antibody products that neutralize specific variants of the virus. Finally, in a new guidance, FDA sets out its policy for evaluating the impact of viral mutations on COVID-19 tests. The guidance provides specific recommendations for assessing the impact of viral mutations on molecular diagnostics, antigen tests and serology tests and explains that FDA is considering including a condition of authorization for test developers in EUAs that would require them to evaluate the impact of virus mutations on test performance.