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

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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