CBER 101 - Biologics License Application Process
CBER 101 - Biologics License Application Process
CBER 101 - Biologics License Application Process
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Electronic Submissions<br />
• Submission of BLA/S may be made on paper or<br />
electronically<br />
• Submissions should be made in accordance with<br />
published guidance:<br />
– http://www.fda.gov/cber/esub/esub.htm<br />
C<br />
E<br />
B<br />
R
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