Center for Drug Evaluation and Research

Results: 4314



#Item
561Food and Drug Administration / Medicine / Counterfeit consumer goods / Pharmacology / Pharmaceutical industry / Office of Criminal Investigations / Online pharmacy / Counterfeit medications / Center for Drug Evaluation and Research / Pharmaceuticals policy / Health / Pharmaceutical sciences

DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service _________________________________________________________________________________________________________ Food and Drug Administration

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Source URL: docs.house.gov

Language: English - Date: 2014-02-26 17:53:17
562Childbirth / Blood banks / Hematology / Cord blood bank / Blood / Cord blood / Cell therapy / Blood donation / Cryopreservation / Biology / Stem cells / Anatomy

Memorandum Food and Drug Administration Center for Biologics Evaluation and Research Office of Compliance and Biologics Quality Division of Manufacturing and Product Quality

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Source URL: www.fda.gov

Language: English
563Benzazepines / Lorcaserin / Myocardial infarction / Relative risk / Cerebrovascular disease / Placebo / Vascular disease / Medicine / Health / Organochlorides

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Addendum to the FDA Briefing Document

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Source URL: www.fda.gov

Language: English
564Hepatitis B immune globulin / HIV/AIDS / Food and Drug Administration / Hepatitis B / Viral hepatitis / Post-exposure prophylaxis / Lamivudine / Center for Biologics Evaluation and Research / Medicine / Health / Hepatitis

PDF Document

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Source URL: www.fda.gov

Language: English
565Medicine / Pharmacology / Pharmaceutical industry / Center for Biologics Evaluation and Research / Pre-clinical development / Biologic / Regulatory requirement / New Drug Application / Food and Drug Administration / Pharmaceutical sciences / Clinical research

FDA Expectations for INDs for Cellular and Gene Therapy Richard D. McFarland Ph.D., M.D. Acting, Associate Director of Policy CBER/OCTGT

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Source URL: www.gtrp.org

Language: English - Date: 2010-05-28 12:00:58
566Food and Drug Administration / Transfusion related acute lung injury / Center for Biologics Evaluation and Research / American Red Cross / Court reporter / Rhode Island Avenue – Brentwood / Medicine / Health / Law

1 U.S. FOOD AND DRUG ADMINISTRATION + + + + + CENTER FOR BIOLOGICS EVALUATION AND RESEARCH + + + + +

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Source URL: www.fda.gov

Language: English - Date: 2007-05-30 10:56:37
567Stem cells / Transplantation medicine / Childbirth / Graft-versus-host disease / Cord blood bank / Hematopoietic stem cell transplantation / Cord blood / National Marrow Donor Program / CD34 / Biology / Medicine / Health

BLA STNs# [removed] &[removed]I concur with this review. M. Serabian[removed]; re-concurred on[removed]FOOD AND DRUG ADMINISTRATION Center for Biologics Evaluation and Research Office of Cellular, Tissue and Gene Ther

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Source URL: www.fda.gov

Language: English
568Pharmaceutical sciences / Clinical research / Pharmaceutical industry / Traumatology / Design of experiments / Pharmacovigilance / Adverse event / Gingivitis / Clinical trial / Medicine / Health / Pharmacology

Food and Drug Administration Center for Biologics Evaluation and Research Office of Biostatistics and Epidemiology Final Review Memorandum: GINTUIT OBE/DE Review for Pharmacovigilance Planning

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Source URL: www.fda.gov

Language: English
569Pharmaceutical sciences / Clinical research / Pharmacology / Pharmaceutical industry / Medical statistics / Center for Biologics Evaluation and Research / New Drug Application / Clinical trial / Medical device / Medicine / Food and Drug Administration / Health

Guidance for Industry Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products U.S. Department of Health and Human Services

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Source URL: www.fda.gov

Language: English
570Safety / Pharmacology / Drug safety / Drugs / Pharmaceuticals policy / Title 21 of the Code of Federal Regulations / Over-the-counter drug / Center for Drug Evaluation and Research / United States Department of Health and Human Services / Health / Medicine / Food and Drug Administration

Monday, May 11, 2009 Part VI Department of

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Source URL: www.gpo.gov

Language: English - Date: 2010-07-29 07:20:56
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