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Center for Biologics Evaluation and Research
Results: 1843

#	Item
31	file://C:uments%20and%20SettingswnadktopLic Add to Reading List Source URL: www.anthrax.mil Language: English - Date: 2004-05-17 07:47:34 Safety Drug safety Public safety Vaccine Adverse Event Reporting System Patient safety Adverse effect Center for Biologics Evaluation and Research Medicine Health Food and Drug Administration
32	file://C:uments%20and%20SettingswnadktopLic Add to Reading List Source URL: www.anthrax.mil Language: English - Date: 2004-03-08 15:15:02 Food and Drug Administration Anthrax Drug safety Vaccines Public safety Vaccine Adverse Event Reporting System Anthrax vaccines Adverse effect Center for Biologics Evaluation and Research Medicine Health Biology
33	Guidance for Industry Environmental Assessment of Human Drug and Biologics Applications U.S. Department of Health and Human Services Food and Drug Administration Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical industry Pharmacology Impact assessment Clinical research Center for Biologics Evaluation and Research Biologic New chemical entity Center for Drug Evaluation and Research Food and Drug Administration Pharmaceutical sciences Medicine
34	M E M O R A N D U M[removed]DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Add to Reading List Source URL: www.fda.gov Language: English Transfusion medicine Hematology Blood products Food and Drug Administration Center for Biologics Evaluation and Research Plasmapheresis Biologic Blood donation MSM blood donor controversy Medicine Anatomy Blood
35	THE SCIENCE OF SMALL CLINICAL TRIALS WORKSHOP Add to Reading List Source URL: events-support.com Language: English - Date: 2012-11-13 15:21:11 Clinical research Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health Food and Drug Administration Medicine Health
36	PIDS Headquarters 1300 Wilson Boulevard, Suite 300 Arlington, VA[removed]Tel: ([removed]Fax: ([removed]removed] Add to Reading List Source URL: www.pids.org Language: English - Date: 2015-01-06 14:29:10 Pharmacology Research Clinical research Pharmaceutical industry Center for Biologics Evaluation and Research Biologic Clinical trial Investigational New Drug Center for Devices and Radiological Health Food and Drug Administration Medicine Health
37	Microsoft Word - 11139fnl_09[removed]docx Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Title 21 CFR Part 11 Center for Biologics Evaluation and Research Clinical investigator Medical device Clinical trial Center for Devices and Radiological Health Center for Drug Evaluation and Research Regulatory requirement Food and Drug Administration Medicine Health
38	FDA Guidance Document Concerning Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Research Clinical research Drug safety Pharmacology Center for Biologics Evaluation and Research New Drug Application Validation Investigational New Drug Food and Drug Administration Pharmaceutical industry Medicine
39	Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Research Medicine Clinical research Pharmacology Drug safety Validation Center for Biologics Evaluation and Research Drug Master File Biologic Food and Drug Administration Pharmaceutical industry Pharmaceutical sciences
40	Guidance for Industry Process Validation: General Principles and Practices U.S. Department of Health and Human Services Food and Drug Administration Add to Reading List Source URL: www.variation.com Language: English - Date: 2014-12-31 23:28:16 Pharmaceutics Validation Good manufacturing practice Medical device Food and Drug Administration Quality management system Center for Biologics Evaluation and Research Global Harmonization Task Force Center for Drug Evaluation and Research Pharmaceutical industry Medicine Pharmaceutical sciences

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