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Center for Drug Evaluation and Research
Results: 4314

#	Item
511	FY 2013 BsUFA Financial Report Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmaceutical sciences Biologic Biosimilar Center for Biologics Evaluation and Research Full-time equivalent Center for Drug Evaluation and Research Pharmacology Clinical research Food and Drug Administration
512	Nos[removed]vide[removed], [removed]IN THE Supreme Court of the United States ———— Add to Reading List Source URL: www.americanbar.org Language: English - Date: 2012-10-06 21:56:34 Pharmaceuticals policy Pharmaceutical industry Food and Drug Administration Therapeutics Drug Price Competition and Patent Term Restoration Act Generic drug Abbreviated New Drug Application Pfizer Center for Drug Evaluation and Research Pharmaceutical sciences Pharmacology Health
513	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
514	DEPARTMENT OF HEALTH & HUMAN Add to Reading List Source URL: www.fda.gov Language: English Biology Pharmacology Neurological disorders Botulinum toxin Plastic surgery Center for Biologics Evaluation and Research Spasmodic torticollis Biologic Title 21 of the Code of Federal Regulations Medicine Health Food and Drug Administration
515	BIOGRAPHICAL INFORMATION Janet Woodcock, M.D. Janet Woodcock is Director of the Center for Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). Dr. Woodcock first joined CDER in[removed]For three Add to Reading List Source URL: docs.house.gov - Date: 2014-04-04 13:28:29
516	CLINICAL REVIEW Division of Clinical Evaluation, Office of Cellular Tissue and Gene Therapy, Center for Biologics Evaluation and Research; with consultation from the Office of Device Evaluation, Division of Anesthesiolog Add to Reading List Source URL: www.fda.gov Language: English Biology Clinical research Pharmacology Pharmaceutical industry Design of experiments Center for Biologics Evaluation and Research Mucogingival junction Clinical trial Prescription Drug User Fee Act Food and Drug Administration Health Medicine
517	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 Stem cells Technology Packaging ISBT 128 Transfusion medicine Pharmaceutical industry Label Cord blood bank Cord blood Biology Medicine Childbirth
518	Competencies for All CDER Staff Add to Reading List Source URL: www.fda.gov Language: English Clinical research Food and Drug Administration Therapeutics United States Public Health Service Center for Drug Evaluation and Research Bioequivalence Pharmaceutical sciences Pharmacology Research
519	Public Workshop: Statistical Process Controls for Blood Establishments Add to Reading List Source URL: www.fda.gov Language: English Clinical research Food and Drug Administration Blood banks Center for Biologics Evaluation and Research Influenza Biologic Validation Whole blood Pharmacology Pharmaceutical sciences Medicine
520	Guidance for Industry Providing Regulatory Submissions in Electronic Format - General Considerations Add to Reading List Source URL: www.fda.gov Language: English Health ISO standards Pharmaceutical industry Pharmaceuticals policy Title 21 CFR Part 11 United States administrative law Portable Document Format Center for Biologics Evaluation and Research Arial Food and Drug Administration Medicine Pharmaceutical sciences

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