Good Clinical Practice

Results: 1284



#Item
981Pharmacology / Clinical research / Drug discovery / Medical statistics / Clinical trial / Drug development / Food and Drug Administration / Good Clinical Practice / Pharmaceutical industry / Research / Pharmaceutical sciences

FDA Perspective on International Clinical Trials

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Source URL: www.fda.gov

Language: English
982Clinical research / Center for Food Safety and Applied Nutrition / Center for Biologics Evaluation and Research / Center for Devices and Radiological Health / FDA Warning Letter / Center for Drug Evaluation and Research / Good Clinical Data Management Practice / Food and Drug Administration / Medicine / Health

FDA Enforcement Statistics Summary

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Source URL: www.fda.gov

Language: English
983Pharmaceutical industry / Pharmaceuticals policy / Clinical pharmacology / Food and Drug Administration / Pharmacology / United States Public Health Service / Nuclear pharmacy / Good manufacturing practice / Validation / Medicine / Pharmaceutical sciences / Health

EDIT: Scanned into WORD document by ORA, [removed], edited into correct page format, other edits noted in blue. PROGRAM 7356.002C CHAPTER 56 - DRUG QUALITY ASSURANCE SUBJECT:

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Source URL: www.fda.gov

Language: English
984Clinical research / Food and Drug Administration / Medicinal chemistry / Good Laboratory Practice / Organisation for Economic Co-operation and Development / Pharmaceutical sciences

. * OD LA130 RATORY PRACTICE

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Source URL: www.fda.gov

Language: English
985Food and drink / Food safety / Clinical pharmacology / Pharmacology / United States Public Health Service / Center for Food Safety and Applied Nutrition / Good manufacturing practice / Food Safety and Modernization Act / Applied Food Technologies / Food and Drug Administration / Safety / Health

FDA’s Action Plan for Import Safety

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Source URL: www.fda.gov

Language: English
986Pharmacology / Research / Clinical research / Drug safety / MedWatch / New Drug Application / Good manufacturing practice / Adverse event / Form FDA 483 / Food and Drug Administration / Pharmaceutical industry / Pharmaceutical sciences

CPGM[removed]Drug Quality Reporting System (DQRS); Medwatch Reports); NDA Field Alert Reports (FARS)

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Source URL: www.fda.gov

Language: English
987Pharmaceutical sciences / Pharmaceuticals policy / Pharmaceutical industry / Food law / Clinical research / Center for Food Safety and Applied Nutrition / Center for Veterinary Medicine / New Drug Application / Good manufacturing practice / Food and Drug Administration / Medicine / Health

[removed]Federal Register / Vol. 75, No[removed]Tuesday, December 7, [removed]Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Nunber of respondents

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Source URL: www.gpo.gov

Language: English - Date: 2013-05-23 10:45:19
988Clinical research / Center for Food Safety and Applied Nutrition / Center for Biologics Evaluation and Research / Center for Devices and Radiological Health / FDA Warning Letter / Center for Drug Evaluation and Research / Good Clinical Data Management Practice / Food and Drug Administration / Medicine / Health

FDA Enforcement Statistics Summary Fiscal Year 2010

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Source URL: www.fda.gov

Language: English
989Health / Food and Drug Administration / Medicine / Drug discovery / Pharmacology / Regulatory requirement / Investigational New Drug / Clinical trial / Drug development / Research / Pharmaceutical industry / Clinical research

Good Review Practice: Clinical Review of Investigational New Drug Applications This document has been prepared by the Office of New Drugs in the Center for Drug Evaluation and Research at the Food and Drug Administration

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Source URL: www.fda.gov

Language: English
990Food and Drug Administration / Pharmaceutical industry / Pharmacology / Center for Veterinary Medicine / Good Clinical Practice / Communications protocol / Case report form / Pharmaceutical sciences / Research / Clinical research

#215 Guidance for Industry Target Animal Safety and Effectiveness Protocol Development and Submission Submit comments on this guidance at any time. Submit written comments to the Division of Dockets Management (HFA-305),

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Source URL: www.fda.gov

Language: English
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