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Bla Bla
Results: 1118

#	Item
881	BLA[removed]Resubmission CMC Review of Complete Response letter items (including 483 items) and additional information not contained in original submission azficel-T (LAVIV®) Fibrocell Technologies, Inc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Cleaning Cleanroom software engineering Software quality Validation Aseptic processing Form FDA 483 Packaging and labeling Review Technology Business Science
882	SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA) Version # 7 Effective Date: April 25, 2013 ___________________________________________________________ Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical sciences Food law Prescription Drug User Fee Act Drug safety Center for Biologics Evaluation and Research New Drug Application Federal Food Drug and Cosmetic Act FDA Special Protocol Assessment Food and Drug Administration Medicine Pharmaceuticals policy
883	MEDICAL FINAL REVIEW MEMORANDUM OF ORIGINAL BLA [See also “MEDICAL FINAL REVIEW MEMORANDUM OF ORIGINAL BLA – REVISION #2 [Revision to 03 March 2010 memo]”] TO: FILE STN: [removed], IND -(b)(4)SPONSOR: KAMADA Add to Reading List Source URL: www.fda.gov Language: English Clinical research Design of experiments B vitamins Clinical trial Niacin Emphysema Medicine Health Alpha 1-antitrypsin
884	Microsoft Word - SAN_FRANCISCO[removed]v1-361230_-_DRAFT_-_APPENDIX_IV_-_BLA… Add to Reading List Source URL: gao.gov Language: English - Date: 2013-10-17 16:59:52 Environment Building engineering Green building Low-energy building Sustainable architecture Sustainable building United States Department of Energy United States Environmental Protection Agency Architecture Energy in the United States Construction
885	Hiberix BLA Clinical Review Page[removed]DEPARTMENT OF HEALTH & HUMAN SERVICES FDA/CBER/OVRR/DVRPA Date: July 8, 2009 Add to Reading List Source URL: www.fda.gov Language: English Biology Bacterial diseases Vaccination Microbiology Virology Immunogenicity DPT vaccine Pertussis Hepatitis B vaccine Medicine Vaccines Health
886	CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW ______________________________________________________________________ BLA: Submission Dates: Brand Name Add to Reading List Source URL: www.fda.gov Language: English Organic chemistry Ribavirin Triazoles Cytokines Amines Interferon Methadone Hepatitis C and HIV co-infection Nitazoxanide Antivirals Pharmacology Chemistry
887	CLINICAL PHARMACOLOGY REVIEW BLA[removed], supplement 22 Submission Date: Add to Reading List Source URL: www.fda.gov Language: English Anatomy Tocilizumab Organic chemistry Methadone Rheumatoid arthritis Chemistry Immunosuppressants Amines
888	BLA_125284/0 Antithrombin alfa (ATryn) Add to Reading List Source URL: www.fda.gov Language: English Antithrombin Coagulation system Methadone Etomidate Chemistry Amines Organic chemistry
889	Memorandum Subject: BLA STN: [removed]Kamada-API [Alpha 1 Proteinase Inhibitor (Human) Intravenous] Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmacy Acute phase proteins Alpha 1-antitrypsin Pharmacovigilance Adverse event Medicine Pharmaceutical sciences Health
890	SOPP[removed]Appendix 2) - Intercenter Request for Consultative or Collaborative Review Form Add to Reading List Source URL: www.fda.gov Language: English BLA Fax Internet Computing Technology Email Electronic documents

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