CDER chief says 'standards have not changed,' explaining increase in CRLs for biologics

Zachary Brennan

Senior Editor

The FDA initially rejected nearly half of all biologics applications received last year, many for quality-related CMC issues that need to be improved upon, according …

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CDER chief says 'standards have not changed,' explaining increase in CRLs for biologics

Zachary Brennan

Senior Editor

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Viridian Therapeutics

Waltham, MA, USA

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CDER chief says 's­tan­dards have not changed,' ex­plain­ing in­crease in CRLs for bi­o­log­ics

Senior Editor

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Viridian Therapeutics

Waltham, MA, USA

CDER chief says 'standards have not changed,' explaining increase in CRLs for biologics