Center for Drug Evaluation and Research

Results: 4314



#Item
71Working time / Technology / Webcast / Compounding / Plug-in / Pharmacy / Adobe Connect / Computer-mediated communication / Computing / Break

February 23-24, 2015 Meeting of the Pharmacy Compounding Advisory Committee (PCAC) - Webcast Recording The Center for Drug Evaluation and Research (CDER) provided a live webcast of the February 23-24, 2015, meeting of th

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Source URL: www.fda.gov

Language: English
72Clinical research / Center for Drug Evaluation and Research / Center for Biologics Evaluation and Research / Center for Devices and Radiological Health / Food and Drug Administration / Medicine / Health

THE SCIENCE OF SMALL CLINICAL TRIALS WORKSHOP

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Source URL: events-support.com

Language: English - Date: 2012-11-13 15:21:11
73Pharmacology / Research / Clinical research / Pharmaceutical industry / Center for Biologics Evaluation and Research / Biologic / Clinical trial / Investigational New Drug / Center for Devices and Radiological Health / Food and Drug Administration / Medicine / Health

PIDS Headquarters 1300 Wilson Boulevard, Suite 300 Arlington, VA[removed]Tel: ([removed]Fax: ([removed]removed]

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Source URL: www.pids.org

Language: English - Date: 2015-01-06 14:29:10
74National Institutes of Health / Rare diseases / Pharmacology / Nursing research / Epidemiology / Clinical trial / Niemann–Pick disease / Rare Diseases Clinical Research Network / Biomarker / Health / Medicine / Research

WORKSHOP SUMMARY Sponsored by: Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) Office of the Commissioner, Office of Orphan Products Development (OOPD), FDA National Institutes of Healt

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Source URL: events-support.com

Language: English - Date: 2012-06-15 15:38:24
75Pharmaceutical sciences / Title 21 CFR Part 11 / Center for Biologics Evaluation and Research / Clinical investigator / Medical device / Clinical trial / Center for Devices and Radiological Health / Center for Drug Evaluation and Research / Regulatory requirement / Food and Drug Administration / Medicine / Health

Microsoft Word - 11139fnl_09[removed]docx

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76Pharmaceutical sciences / Research / Clinical research / Drug safety / Pharmacology / Center for Biologics Evaluation and Research / New Drug Application / Validation / Investigational New Drug / Food and Drug Administration / Pharmaceutical industry / Medicine

FDA Guidance Document Concerning

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77Research / Medicine / Clinical research / Pharmacology / Drug safety / Validation / Center for Biologics Evaluation and Research / Drug Master File / Biologic / Food and Drug Administration / Pharmaceutical industry / Pharmaceutical sciences

Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.

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78Chemistry / Pyridines / Thiazoles / Clinical pharmacology / Food and Drug Administration / United States Public Health Service / Ventilator-associated pneumonia / Ceftazidime / Off-label use / Pharmacology / Pharmaceutical sciences / Medicine

Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes of the Anti-Infective Drugs Advisory Committee Meeting December 5, 2014 Location: The Marriott Inn and Conference Center, University o

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79Pharmaceutics / Validation / Good manufacturing practice / Medical device / Food and Drug Administration / Quality management system / Center for Biologics Evaluation and Research / Global Harmonization Task Force / Center for Drug Evaluation and Research / Pharmaceutical industry / Medicine / Pharmaceutical sciences

Guidance for Industry Process Validation: General Principles and Practices U.S. Department of Health and Human Services Food and Drug Administration

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Source URL: www.variation.com

Language: English - Date: 2014-12-31 23:28:16
80Pharmaceutical sciences / Center for Drug Evaluation and Research / Prescription Drug User Fee Act / Center for Biologics Evaluation and Research / Food and Drug Administration / Medicine / Health

Capital Reporting Company FDA -- Meta-Analysis Guidance[removed]1 CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

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Source URL: www.fda.gov

Language: English
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