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Center for Drug Evaluation and Research
Results: 4314

#	Item
221	PDUFA V Annual IT Assessment FY2014 Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act Investigational New Drug Electronic Common Technical Document New Drug Application Center for Biologics Evaluation and Research Adverse Event Reporting System Common Technical Document Food and Drug Administration Medicine Research
222	Office of Generic Drugs Director’s Update – GDUFA Goal Dates: It’s not just about the numbers Building a Quality System” Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Food and Drug Administration Health Abbreviated New Drug Application Generic drug Center for Drug Evaluation and Research Quality management system Pharmaceutical sciences Pharmaceutical industry Pharmaceuticals policy
223	User Fees According to Goldilocks: Getting Your User Fees Just Right October 27, 2014 Center for Drug Evaluation and Research (CDER) – Office of Management Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical industry Health policy Prescription Drug User Fee Act Center for Drug Evaluation and Research Generic drug Fee Food and Drug Administration Pharmaceuticals policy Pharmaceutical sciences
224	[removed]Federal Register / Vol. 63, No[removed]Thursday, May 14, [removed]Proposed Rules failure of the hydraulic extension system, accomplish the following: Add to Reading List Source URL: www.fda.gov Language: English Stem cells Cell biology Biotechnology Developmental biology Current Good Tissue Practices Allotransplantation Cell therapy Center for Biologics Evaluation and Research Cord blood Biology Medicine Food and Drug Administration
225	7th Annual International Conference for Rare Diseases and Orphan Drugs Regulatory Aspects of Orphan Drugs – FDA Perspective Debra Lewis, OD, MBA Deputy Director Add to Reading List Source URL: icord.se Language: English - Date: 2012-07-24 07:43:02 Food and Drug Administration Pharmaceuticals policy Drug discovery Orphan drug Pharmacology Center for Drug Evaluation and Research Rare disease Orphan Drug Act Pharmaceutical sciences Clinical research Health
226	Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and Food and Drug Administration Staff Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Stem cells Transplantation medicine Blood banks Allotransplantation Immunology Center for Biologics Evaluation and Research Tissue Bone Biology Medicine Anatomy
227	FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER) Anti-Infective Drug Advisory Committee (AIDAC) Meeting The Marriott Inn and Conference Center, University of Maryland University College ( Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Clinical pharmacology Pharmaceutical industry Pharmaceuticals policy Center for Drug Evaluation and Research Clinical investigator Infectious Diseases Society of America Drug discovery Antimicrobial Pharmaceutical sciences Pharmacology Medicine
228	FOOD AND DRUG ADMINISTRATION Center for Drug Evaluation and Research Oncologic Drugs Advisory Committee Roster Chairperson Deborah K. Armstrong, MD Expertise: Medical Oncology, Cancer Genetics Add to Reading List Source URL: www.fda.gov Language: English Women physicians Douglas Blayney Ian Olver Medicine Oncologists Year of birth missing
229	FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER) Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) FDA White Oak Campus, Building 31, the Great Room (Rm[removed]Whi Add to Reading List Source URL: www.fda.gov Language: English Clinical research Clinical pharmacology Therapeutics United States Public Health Service Center for Drug Evaluation and Research Alexion Pharmaceuticals Eculizumab Food and Drug Administration Pharmacology Pharmaceutical sciences
230	FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER) Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (pedsODAC) FDA White Oak Campus, Building 31, the Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Clinical pharmacology Therapeutics United States Public Health Service Center for Drug Evaluation and Research Patient safety Oncology Neuroblastoma Medicine Health Food and Drug Administration

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