CBER 101 - Biologics License Application Process
CBER 101 - Biologics License Application Process
CBER 101 - Biologics License Application Process
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Good Review Management<br />
Principles<br />
• Presubmission<br />
• <strong>Application</strong> Receipt <strong>Process</strong>ing (Prefiling)<br />
• Filing<br />
• Review Planning<br />
• Review<br />
• Advisory Committee Meetings<br />
• Wrap Up and Labeling<br />
• Action<br />
• Cycles of Review<br />
C<br />
E<br />
B<br />
R