CBER 101 - Biologics License Application Process
CBER 101 - Biologics License Application Process
CBER 101 - Biologics License Application Process
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PDUFA Resubmissions<br />
• Guidance for Industry: Classifying Resubmissions<br />
in Response to Action Letters, May 14, 1998<br />
• SOPP 8405.1 Procedures for the Classification of<br />
Resubmissions of an <strong>Application</strong> for a Product<br />
Covered by PDUFA III<br />
C<br />
E<br />
B<br />
R