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Electronic common technical document
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191	Notice- Electronic Templates for the Quality Information of Drug Submissions for Biological Products and Radiopharmaceuticals Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-07-12 14:26:55 Application software Clinical Data Management Pharmacology Health Canada Health Products and Food Branch Common Technical Document Biologic WordPerfect Template Software Computing Word processors
192	Microsoft Word - ctd_prep_rev_nds-eng.doc Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2014-06-17 11:30:03 Research Technology Pharmaceutical industry Medical informatics Electronic Common Technical Document Common Technical Document Global Harmonization Task Force Drug Master File Clinical trial Medicine Clinical research Clinical Data Management
193	Microsoft Word - qa_qr_guide_ectd-eng.doc Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-07-12 14:26:06 Medicine Pharmaceutical industry Medical informatics Electronic Common Technical Document Food and Drug Administration Common Technical Document Health Canada Electronic submission Filing Clinical Data Management Clinical research Research
194	Microsoft Word - 11000fnl_02[removed]docx Add to Reading List Source URL: www.fda.gov Language: English Clinical research Health Pharmaceutical industry Drug safety Clinical Data Management Investigational New Drug Prescription Drug User Fee Act Electronic Common Technical Document New Drug Application Food and Drug Administration Medicine Research
195	Notice - Electronic Specifications for Clinical Trial Applications and Amendments Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-06-24 11:52:37 Computing Electronic Common Technical Document Food and Drug Administration Pharmaceutical industry Common Technical Document Clinical trial Computer file Portable Document Format Clinical research Research Clinical Data Management
196	Guidance for Industry Providing Regulatory Submissions in Electronic Format Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Health Drug safety Clinical Data Management Pharmaceutical industry Electronic Common Technical Document Investigational New Drug Common Technical Document Title 21 CFR Part 11 Medicine Research Clinical research
197	PDUFA IV IT PLAN ABBREVIATED UPDATE MAY 2010 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Medicine Prescription Drug User Fee Act Electronic Common Technical Document Regulated Product Submissions Food and Drug Administration Pharmaceuticals policy Health
198	Microsoft Word - r_52_125325.0 Information Request - 18 June 2010.doc Add to Reading List Source URL: www.fda.gov Language: English Clinical research Clinical Data Management Pharmacology Electronic Common Technical Document Center for Biologics Evaluation and Research Biologic License Application Food and Drug Administration Medicine Research
199	U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Drug safety Food and Drug Administration Medical informatics Electronic Common Technical Document Common Technical Document New Drug Application Electronic submission Investigational New Drug Research Clinical Data Management Clinical research
200	PDUFA V Information Technology Plan (Draft) FY[removed]FY 2017 Add to Reading List Source URL: www.fda.gov. Language: English Research Clinical research Medical informatics Clinical Data Management Drug safety Electronic Common Technical Document Prescription Drug User Fee Act Clinical Data Interchange Standards Consortium Investigational New Drug Food and Drug Administration Health Medicine

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