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Biologic License Application
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#	Item
31	Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmaceuticals policy Pharmacology Pharmaceutical industry Center for Biologics Evaluation and Research Biologic License Application Biologic Good manufacturing practice Regulatory requirement Food and Drug Administration Medicine Health
32	Guidance on Blood and Blood for Transfusion of Further Manufacture Add to Reading List Source URL: www.fda.gov Language: English Blood Transfusion medicine Pharmaceutical industry Pharmaceuticals policy Clinical research Validation Plasmapheresis Blood bank Biologic License Application Medicine Food and Drug Administration Health
33	Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmaceuticals policy Pharmacology Pharmaceutical industry Center for Biologics Evaluation and Research Biologic License Application Biologic Good manufacturing practice Regulatory requirement Food and Drug Administration Medicine Health
34	Appendix 1: Medical Device User Fee Cover Sheet Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Prescription Drug User Fee Act Center for Devices and Radiological Health Medical device Fee Biologic License Application Food and Drug Administration Medicine Health
35	REQUEST FOR EXTENSION OF COMMBNT PERIOD Requirements for Foreign and Domestic Esrablishment Registration and Listing for Hurnan Drugs, Including Drugs tJlot are Regulated Under a Biologics License Application, and An.i Add to Reading List Source URL: www.fda.gov Language: English - Date: 2007-01-12 17:12:23 Food and Drug Administration Pharmaceuticals policy Drug safety Therapeutics Pharmaceutical industry Over-the-counter drug Animal drugs Biologic License Application Monograph Pharmaceutical sciences Pharmacology Medicine
36	[removed]Federal Register / Vol. 79, No[removed]Tuesday, August 5, [removed]Notices III. Electronic Access Persons interested in obtaining a copy Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2014-10-07 08:58:36 Pharmaceutical sciences Biosimilar Biologic License Application Center for Biologics Evaluation and Research Biologic Center for Devices and Radiological Health Center for Drug Evaluation and Research Food and Drug Administration Medicine Clinical research
37	Report In Brief U.S. Department of Commerce Office of Inspector General March 2005 Why We Did This Review Add to Reading List Source URL: www.oig.doc.gov Language: English - Date: 2014-03-07 17:14:10 Export Bureau of Industry and Security Military science CCL Chemical Weapons Convention Biologic License Application Dual-use technology International relations Military technology International trade
38	DEPARTMENT OF HEALTH & HUMAN SERVICES December 17, 2002 CERTIFIED MAIL Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-02-25 07:23:50 Pharmaceutical sciences Biologic License Application Center for Biologics Evaluation and Research Federal Food Drug and Cosmetic Act Debarment Food and Drug Administration Medicine Health
39	DEPARTMENT OF HEALTH & HUMAN SERVICES December 17, 2002 CERTIFIED MAIL RETURN RECEIPT Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-02-25 07:23:50 Health Pharmacology Pharmaceuticals policy Food law Therapeutics Debarment Biologic License Application Pharmaceutical industry Center for Biologics Evaluation and Research Food and Drug Administration Pharmaceutical sciences Medicine
40	DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-08 14:30:44 Drug safety Pharmacology Medical research Drotrecogin alfa Intensive care medicine New Drug Application Eli Lilly and Company Biologic License Application Term of patent in the United States Medicine Food and Drug Administration Health

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