Sign up here for GlobalData's free bi-weekly Covid-19 report on the latest information your industry needs to know.The US Food and Drug Administration (FDA) has released guidance with recommendations for the manufacturing, clinical development and approval of a Covid-19 vaccine.
While the development and review processes are being accelerated to address the ongoing pandemic, the FDA will require data to be submitted to meet its regulatory standards.
Named Development and Licensure of Vaccines to Prevent Covid-19, the guidance covers requirements for chemistry, manufacturing and control, nonclinical and clinical data.
Read more on pharmaceutical-technology.com