Center for Drug Evaluation and Research

Results: 4314



#Item
101Clinical research / Center for Drug Evaluation and Research / United States Department of Health and Human Services / Medicinal chemistry / Food and Drug Administration / Pharmaceutical sciences / Pharmacology

FOOD AND DRUG ADMINISTRATION

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Source URL: www.fda.gov

Language: English
102Food and Drug Administration / Pharmacology / Therapeutics / United States Public Health Service / Center for Drug Evaluation and Research / Medicinal chemistry / Medical Representatives Certification Commission / Genomic Medicine Institute / Pharmaceutical sciences / Clinical research / Clinical pharmacology

Microsoft Word[removed]FDA EMDAC - Revised[removed]_Transcript_.doc

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Source URL: www.fda.gov

Language: English
103Doctor of Philosophy / Titles / Doctor of Medicine / Center for Biologics Evaluation and Research / Education / Academia / Knowledge

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring, MD[removed]MID-CYCLE MEETING SUMMARY To:

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Source URL: www.fda.gov

Language: English
104Research / 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Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.

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Source URL: www.fda.gov

Language: English
105Pharmaceutical industry / Microbiology / Validity / Clinical research / Validation / Recombinant DNA / Meningococcal disease / Cleaning validation / Novartis / Biology / Quality / Biotechnology

DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Center for Biologics Evaluation and Research[removed]New Hampshire Ave

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Source URL: www.fda.gov

Language: English
106AstraZeneca / Vaccines / Epidemiology / Influenza / FluMist / Center for Biologics Evaluation and Research / MedImmune / Food and Drug Administration / Medicine / Health / Vaccination

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 1401 Rockville Pike

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Source URL: www.fda.gov

Language: English
107Medicine / Pharmaceutical industry / Food and Drug Administration / Chemical engineering / Tablet / Abbreviated New Drug Application / Time release technology / Center for Drug Evaluation and Research / Pill splitting / Pharmaceutical sciences / Pharmacology / Dosage forms

Guidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation U.S. Department of Health and Human Services

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Source URL: www.fda.gov

Language: English
108Design of experiments / Science / Clinical trial / Pharmaceutical industry / Pharmacology / Health / Research / Epidemiology / Clinical research

CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125511Orig1s000

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2015-02-06 06:50:18
109Pharmaceutical industry / Validity / Pharmacology / Clinical research / Food and Drug Administration / Center for Biologics Evaluation and Research / Endotoxin / Novartis / Validation / Medicine / Pharmaceutical sciences / Science

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD[removed]CBER REGULATORY REVIEW MEMORANDUM Date

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Source URL: www.fda.gov

Language: English
110Medicine / Clinical research / Investigational New Drug / Expanded access / Drug development / Center for Drug Evaluation and Research / Food and Drug Administration / Pharmacology / Pharmaceutical sciences

[removed]Federal Register / Vol. 80, No[removed]Tuesday, March 3, [removed]Notices TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1—Continued[removed]b), Number of submissions to FDA of ‘‘supporting informati

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Source URL: www.gpo.gov

Language: English - Date: 2015-03-03 11:27:09
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