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Keywords: Fda, Biologic, License, Cder, Licensure

Related Terms: Approval, Inducer, Phytosanitary Certificate, Prior Approval, Dna Vaccine, Investigational New Drug Application, Cmc , Gmp, Ind Application, Irb, Expedited Review, Registration, Food And Drug Administration, Pharmacogenomics, Institutional Review Board, Investigational New Drug, Approved, Indication, Institutional Animal Care And Use Committee, Anda, Cta, Phase Iv, Accelerated Approval, Biopharmaceutical, Emea, Chimeric Antibody, Approved, Certification, Certification, Nda, New Drug Application, Orphan Drug Designation, Compassionate Use, Maa, Certification, Monitoring, Ind , Srg , Pma, Csr, Fda, Certified Organic, Pharmaceuticals, Inspection, Investigational Drug, Reb, Off-Label Use, Cgmp, Off-Label

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Biologics License Application, which is an application to FDA for a license to market a new biological product in the United States

http://csdd.tufts.edu/InfoServices/Glossary.asp

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Biologics License Application (USA) Used to submit specified biotechnology products, such as those manufactured by recombinant DNA technology and monoclonal antibody products, for marketing approval by the FDA.

http://bioprocessintl.com/default.asp?page=glossary&TopicID=3

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Biological License Approval

http://tw.us.biz.yahoo.com/e/060314/ile10

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Biologic Licensure Applications

http://answers.google.com/answers/threadview?id=721430

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