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Center for Drug Evaluation and Research
Results: 4314

#	Item
521	FY 2013 PDUFA Financial Report Add to Reading List Source URL: www.fda.gov Language: English Medicine Prescription Drug User Fee Act Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Cost Clinical trial Office of Regulatory Affairs Food and Drug Administration Pharmaceutical sciences Health
522	Attachment E CDRH Final Guidance Cover Sheet Add to Reading List Source URL: www.fda.gov Language: English Food law Pharmaceuticals policy Unique Device Identification Medical equipment Medical device Title 21 of the Code of Federal Regulations Center for Biologics Evaluation and Research Regulatory requirement Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
523	Microsoft Word - 7074fnl.doc Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmaceutical industry Structured Product Labeling Clinical research Drug safety New Drug Application Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Health Level 7 Medicine Medical informatics Health
524	The Roles of Stat at CDER/FDA Add to Reading List Source URL: www.amstat.org Language: English - Date: 2014-07-29 08:28:25 Clinical research Medicine Pharmaceutical industry Drug safety Therapeutics Center for Drug Evaluation and Research New Drug Application Investigational New Drug Drug development Food and Drug Administration Pharmaceutical sciences Pharmacology
525	Food and Drug Administration Center for Drug Evaluation and Research Joint Meeting of the Medical Imaging Drugs Committee and the Oncologic Drugs Advisory Committee May 3, 2013 Errata and Clarification to the FDA Briefin Add to Reading List Source URL: www.fda.gov Language: English Sargramostim Neutropenia Food and Drug Administration Pharmaceutical sciences Medicine Pharmacology
526	Information Request Eamil, July 7, [removed]GINTUIT Add to Reading List Source URL: www.fda.gov Language: English Health Pharmacovigilance Food and Drug Administration Center for Biologics Evaluation and Research Risk assessment Pharmaceutical sciences Pharmacology Medicine
527	Drug Name Presentation Title Add to Reading List Source URL: www.fda.gov Language: English Medicine Food law Pharmaceutical sciences Pharmacology United States Public Health Service Orphan drug Federal Food Drug and Cosmetic Act Center for Drug Evaluation and Research Food and Drug Administration Amendments Act Food and Drug Administration Pharmaceuticals policy Health
528	Workshop on Data and Data Needs to Advance Risk Assessment Add to Reading List Source URL: www.fda.gov Language: English Microbiology Epidemiology Transfusion medicine Center for Biologics Evaluation and Research Influenza Disease Lyme disease Blood donation Food and Drug Administration Medicine Biology Health
529	Slides for APAC Feb. 10, 2000 from Dr. Pastor Add to Reading List Source URL: www.fda.gov Language: English - Date: 2000-02-09 02:50:21 Drug rehabilitation Amines Eli Lilly and Company Ketones Methadone Placebo Center for Biologics Evaluation and Research Medicine Chemistry Health
530	67’hMeeting of Blood Products Advisory Committee Septemberl&2000 Classification of HLA Devices Presentations 1. 2. Add to Reading List Source URL: www.fda.gov Language: English - Date: 2000-09-15 07:44:13 Food and Drug Administration Immune system Genes Human leukocyte antigen Immunology Center for Biologics Evaluation and Research Medical device HLA-B Center for Devices and Radiological Health Medicine Biology Health

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