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Center for Drug Evaluation and Research
Results: 4314

#	Item
701	a1Document; a2Document; a3Document; a4Document; a5Document; a6Document; a7Document; a8Document; a1Technical; a2Technical; a3Tech Add to Reading List Source URL: www.fda.gov Language: English - Date: 1998-03-12 09:33:12 Immune system Immunology Food and Drug Administration Blood products Biotechnology Center for Biologics Evaluation and Research Monoclonal antibodies Biologic Immunoglobulin E Biology Anatomy Medicine
702	Prescription Drug User Fee Act (PDUFA) Webinar 1 Add to Reading List Source URL: www.fda.gov Language: English Medicine Prescription Drug User Fee Act Pharmaceutical sciences FDA Special Protocol Assessment Abbreviated New Drug Application Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Priority review voucher Food and Drug Administration Pharmaceuticals policy Health
703	Nominations from FDA’s Center for Drug Evaluation and Research 1. Genotoxicity and Carcinogenicity testing of Cefuroxime (CDER) Cefuroxime is a semi-synthetic, broad-spectrum cephalosporin antibiotic for oral Add to Reading List Source URL: ntp.niehs.nih.gov Language: English - Date: 2014-11-11 13:05:36 Gram-negative bacteria Pathogenic bacteria Polysaccharide encapsulated bacteria Gram-positive bacteria Cefuroxime Haemophilus influenzae Bronchitis Streptococcus pneumoniae Cephalosporin Bacteria Microbiology Pneumonia
704	UPDATE on GDUFA and FDA’s Office of Generic Drugs Add to Reading List Source URL: www.fda.gov. Language: English Health Medicine Pharmaceutical industry Therapeutics United States Public Health Service Generic drug Abbreviated New Drug Application Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Food and Drug Administration Pharmaceutical sciences Pharmaceuticals policy
705	CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE MEMBERS (Voting) Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmaceutical sciences Center for Drug Evaluation and Research National Institutes of Health Albert Einstein College of Medicine Medicine Health United States Department of Health and Human Services
706	CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE MEMBERS (Voting) Add to Reading List Source URL: www.fda.gov Language: English Clinical pharmacology Food and Drug Administration Pharmacology Therapeutics United States Public Health Service Steven Nissen American College of Cardiology Center for Drug Evaluation and Research Cardiology Medicine Pharmaceutical sciences Clinical research
707	Complex Generic Drugs Robert Lionberger, Ph.D. Deputy Director for Science (acting) Office of Generic Drugs Center for Drug Evaluation and Research, FDA The views presented are those of the authors and do not necessarily Add to Reading List Source URL: www.fda.gov. Language: English Pharmacology Pharmaceuticals policy Food and Drug Administration Abbreviated New Drug Application Generic drug Regulatory science Center for Drug Evaluation and Research Drug development Pharmaceutical sciences Pharmaceutical industry Clinical research
708	MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Center for Biologics Evaluation and Research Add to Reading List Source URL: www.fda.gov Language: English Health Clinical research Food and Drug Administration Clinical pharmacology United States Public Health Service Biologic Center for Biologics Evaluation and Research Medical privacy Surveillance Ethics Pharmacology Privacy
709	2014 FDA Justification of Estimates for Appropriations Committees Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmacology Clinical pharmacology Therapeutics United States Public Health Service Center for Biologics Evaluation and Research Influenza vaccine Criticism of the Food and Drug Administration Prescription Drug User Fee Act Food and Drug Administration Pharmaceutical sciences Medicine
710	U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Center for Drug Evaluation and Research Fibromyalgia Gamma-Hydroxybutyric acid Medicine Health Food and Drug Administration

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