‘Never Again’: Shuren Talks COVID-19 Lessons At FDA Small Business Event
Despite insisting that he would never want to relive the stressful days of 2020, US FDA device center chief Jeff Shuren said the pandemic nevertheless led to improvements in regulatory flexibility and communication with industry.
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The organization ECRI cited emergency use authorized products as the biggest risk in a new report, saying the temporary clearances aren’t built to ensure lasting safety.
The US body says it wants to encourage labs to use newer, faster alternatives that can also detect other pathogens.
MDUFA V: Industry, FDA Tangle Over TAP Program, Agency Finances, Reinstatement Of Fifth-Year Offset Funds
In newly published meeting minutes, industry and the US FDA continued to clash over a proposal to create a new pre-submission advisory program and what to do with carryover user-fee funds.