Scientific Wave Pushes CBER Into Brighter Light
What are US regulators doing to prepare for adequate review of the upcoming wave of gene therapy applications, and what other actions could CBER take to ensure it is able to facilitate the expected onslaught of breakthroughs in this field? Consultant Nancy Bradish Myers weighs in.
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US biologics center is getting back to regular business now that COVID-19 work is subsiding; director Marks credits acting commissioner Woodcock with using all available mechanisms to staff up.
'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.