CBER 101 - Biologics License Application Process
CBER 101 - Biologics License Application Process
CBER 101 - Biologics License Application Process
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Filing Review<br />
• Review for completeness<br />
– RTF policy<br />
– <strong>CBER</strong> SOPP 8404 Refusal to File Guidance for Product<br />
<strong>License</strong> <strong>Application</strong>s and Establishment <strong>License</strong><br />
<strong>Application</strong>s<br />
• Filing meeting<br />
• Filing letter<br />
• Communicate any significant deficiencies noted up<br />
to that time (but not a complete review) by day 74<br />
C<br />
E<br />
B<br />
R