CBER 101 - Biologics License Application Process
CBER 101 - Biologics License Application Process
CBER 101 - Biologics License Application Process
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BLA – Product/Manufacturing<br />
Information<br />
• Source material / raw materials<br />
• Manufacturing process and controls<br />
• Formulation<br />
• Facility information<br />
• Contamination/cross-contamination information<br />
• Environmental assessment or categorical exclusion<br />
C<br />
E<br />
B<br />
R