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Biologics license application
open-in-new
<h2 id="see-also">See also</h2> <ul><li><a href="/facts/New_drug_application/Hdkw0Mzl">New drug application</a></li> <li><a href="/facts/Investigational_new_drug/GTHo92ee">Investigational new drug</a></li></ul> <h2 id="references">References</h2> <ol> <li id="fn:1"><p>"Biologics License Applications (BLA) Process (CBER)". FDA. 2015. Retrieved July 9, 2016. <a href="https://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicsLicenseApplicationsBLAProcess/" target="_blank">https://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicsLicenseApplicationsBLAProcess/</a> <a href="#fnref:1" class="footnote-back-ref">↩</a></p></li> <li id="fn:2"><p>"Archived copy" (PDF). Food and Drug Administration. Archived from the original (PDF) on February 3, 2017. Retrieved January 27, 2017.{{cite web}}: CS1 maint: archived copy as title (link) <a href="https://web.archive.org/web/20170203182832/https://www.fda.gov/downloads/drugs/newsevents/ucm182539.pdf" target="_blank">https://web.archive.org/web/20170203182832/https://www.fda.gov/downloads/drugs/newsevents/ucm182539.pdf</a> <a href="#fnref:2" class="footnote-back-ref">↩</a></p></li> <li id="fn:3"><p>Group, The FDA. "The Biologics License Application (BLA) Process Explained". www.thefdagroup.com. {{cite web}}: |last= has generic name (help) <a href="https://www.thefdagroup.com/thefdgroup-blog/2014/07/test-the-biologics-license-application-bla-process/" target="_blank">https://www.thefdagroup.com/thefdgroup-blog/2014/07/test-the-biologics-license-application-bla-process/</a> <a href="#fnref:3" class="footnote-back-ref">↩</a></p></li> </ol>