FDA issues new guidance on COVID-19 impact on MDUFA goals, meetings.
The guidance provides answers to eight questions on FDA’s handling of meetings during (COVID-19) public health emergency and applications for medical devices.
First 13-minute episode was focused on coronavirus where Commissioner Stephen Hahn, M.D., joined host Anand Shah, M.D., the agency’s deputy commissioner for medical and scientific affairs, discussed development of drugs for COVID-19. New episodes will drop every Tuesday and will focus on different areas of interest for the agency such as products under FDA regulation and issues agency is working to resolve.
Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency has posted a warnings about cyber vulnerabilities affecting four separate Baxter infusion pumps.
DHS warnings include:
© 2020 BeanStock Ventures