US FDA Has Done Over 200 ‘Mission Critical’ Inspections During COVID
For now, agency appears to be in early stages of testing alternative inspection models beyond the flexibility it has been applying throughout the pandemic.
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CMS final rule for hospital payment in 2021 includes enhanced payment for six novel antibiotics – including one that is not yet approved by FDA. New policies to encourage antibiotic innovation are clearly having an impact in the context of Medicare payments.
Medicare’s doubts about trial design for Sage’s postpartum depression therapy suggests even ‘breakthrough’-designated products can struggle with the ‘substantial clinical improvement’ standard for NTAP status. Denial of enhanced payment for Zulresso ends a long winning streak by innovators.
CDER has ‘turned the corner’ on hiring during 2020, acting Director tells stakeholders – though the added workload from COVID-19 makes that hard to see.