Coronavirus (COVID-19) | CBER-Regulated Biologics
The FDA updated its CBER-regulated biologics resource page to provide centralized access to guidance, advice, and contact information for developers of COVID-19 treatments and preventatives.
Biotechnology and pharmaceutical developers seeking to develop or refine CBER-regulated biological therapies for the treatment or prevention of COVID-19.
The consolidation of these resources suggests a continued effort by CBER to streamline communication with sponsors. This centralized access point may help regulatory teams navigate post-emergency phase requirements by providing a direct line to agency assistance and technical guidance, potentially reducing friction during the development lifecycle.
Regulatory affairs teams should utilize the provided contact channels to seek formal assistance and monitor the linked guidance documents for updates to COVID-19 therapy development standards. Ensure development pipelines align with current CBER technical advice.
This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.
Open in openFDA / FDA.gov