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Biologic License Application
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21	Microsoft Word - Press Release U S Army Freeze Dried Plasma FINAL for April[removed]docx Add to Reading List Source URL: vasc.com Language: English - Date: 2014-04-22 13:12:27 Pharmacology Medicine Fresh frozen plasma Freeze-drying Blood plasma Biologic License Application Food and Drug Administration Biologic Blood products Anatomy Biology
22	DEPARTMENT OF HEALTH & HUMAN Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Health Medical informatics Pharmaceutical industry Biologic License Application Biologic Package insert Center for Biologics Evaluation and Research Food and Drug Administration Medicine Pharmacology
23	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Biologic License Application Immunogenicity Center for Biologics Evaluation and Research Package insert Labeling theory Rogalski Medicine Food and Drug Administration Health
24	Interferon alfacon-1 BLA supplement Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Food and Drug Administration Biologic License Application Package insert Adverse effect Biologic Clinical trial Pharmaceutical drug Pharmacology Medicine Health
25	ENFORCEMENT STORY – FY04 Add to Reading List Source URL: www.fda.gov Language: English Research Center for Biologics Evaluation and Research New Drug Application Biologic License Application Form FDA 483 Biologic Clinical research Investigational New Drug Clinical investigator Food and Drug Administration Medicine Health
26	Guidance for Industry: CMC and Establishment Description Info for Human Blood and Blood Components Add to Reading List Source URL: www.fda.gov Language: English Medicine Clinical research Clinical pharmacology Therapeutics United States Public Health Service Biologic License Application Center for Biologics Evaluation and Research Abbreviated New Drug Application Biologic Food and Drug Administration Pharmaceutical sciences Pharmacology
27	[removed]Federal Register / Vol. 73, No[removed]Monday, November 24, [removed]Notices Section 903(b)(2)(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceutical sciences New Drug Application Debarment Center for Biologics Evaluation and Research Federal Food Drug and Cosmetic Act Biologic License Application Investigational New Drug Prescription Drug User Fee Act Criticism of the Food and Drug Administration Food and Drug Administration Medicine Health
28	Microsoft Word - r_52_125325.0 Information Request - 18 June 2010.doc Add to Reading List Source URL: www.fda.gov Language: English Clinical research Clinical Data Management Pharmacology Electronic Common Technical Document Center for Biologics Evaluation and Research Biologic License Application Food and Drug Administration Medicine Research
29	DATE SUBMITTED TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE (21 CFR[removed]) Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceutical sciences Pharmacology Therapeutics United States Public Health Service Paperwork Reduction Act Electronic Common Technical Document Biologic License Application New Drug Application Food and Drug Administration Clinical research Research
30	INSTRUCTIONS FOR FILLING OUT FORM FDA 356h – APPLICATION TO MARKET A NEW OR ABBREVIATED NEW DRUG OR BIOLOGIC FOR HUMAN USE (The field numbers below correspond to the numbered boxes on the Form FDA 356h) NOTE: Please Add to Reading List Source URL: www.fda.gov. Language: English Medicine Drug safety Health Clinical research New Drug Application Investigational New Drug Biologic License Application Drug Master File Food and Drug Administration Pharmaceutical industry Pharmaceutical sciences

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