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Electronic common technical document
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271	Information on the eCTD Module 1 Update and Implementation Plans[removed]Minor changes to the eCTD Module 1 update are being made to reflect the re-designation of ‘Prereview of television advertisements’ from 503B Add to Reading List Source URL: www.fda.gov Language: English Medical informatics Electronic Common Technical Document Pharmaceutical industry Validation Clinical research Clinical Data Management Research
272	Example Submissions using the eCTD Backbone Files Add to Reading List Source URL: www.fda.gov Language: English Clinical Data Management Medical informatics Electronic Common Technical Document Food and Drug Administration ODD New Drug Application Research Clinical research Pharmaceutical sciences
273	AGENDA Public Meeting: eCTD Module 1 Update 8:00AM – 11:30AM Tuesday, September 18, 2012 FDA Great Room 1503 White Oak, Maryland Add to Reading List Source URL: www.fda.gov Language: English Clinical research Medical informatics Clinical Data Management Electronic Common Technical Document Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Business informatics Medicine Food and Drug Administration Research
274	Specifications for eCTD Validation Criteria v3.1 Add to Reading List Source URL: www.fda.gov Language: English Clinical research Medical informatics Electronic Common Technical Document ISO standards Computer file formats Corrective and preventive action XML WAR file format Computing Technology Clinical Data Management
275	Microsoft Word - Addendum to the eCTD Backbone Files Specification for Module 1-v2 3 Add to Reading List Source URL: www.fda.gov Language: English Health Clinical research Drug safety Pharmaceutical industry Clinical Data Management Electronic Common Technical Document Investigational New Drug Drug Master File New Drug Application Food and Drug Administration Medicine Research
276	Microsoft Word - Draft Agenda_SFDA Training_September 27_2012.docx Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-09-27 10:36:09 Clinical research Research MedDRA Center for Biologics Evaluation and Research Electronic Common Technical Document Center for Drug Evaluation and Research Food and Drug Administration Pharmacology Medicine
277	E16 Step 5 Genomic Biomarker related to drug response: context, structure and format of qualification submissions Add to Reading List Source URL: www.ema.europa.eu Language: English - Date: 2013-07-21 06:07:07 Clinical research Pharmaceutical industry Food and Drug Administration Medical research Epidemiology Biomarker Electronic Common Technical Document Proteomics Investigational New Drug Medicine Biology Research
278	consolidated-public-mtg-presentations Add to Reading List Source URL: www.fda.gov Language: English Electronic Common Technical Document HTML element Document Type Definition Scientific method Technology Science Clinical Data Management Medical informatics Clinical research
279	The eCTD BACKBONE FILES SPECIFICATION FOR MODULE 1 Add to Reading List Source URL: www.fda.gov Language: English Markup languages Technical communication Medical informatics Electronic Common Technical Document Document Type Definition HTML element HTML Attribute XML Computing Clinical Data Management Clinical research
280	Federal Register / Vol. 79, No[removed]Thursday, May 15, [removed]Notices The public meeting will be held at the National Aeronautics and Space Administration Headquarters Auditorium, 300 E Street SW., Washington, DC 20546. Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2014-05-19 13:45:17 Clinical Data Management Health Medical informatics Electronic Common Technical Document Pharmaceuticals policy Common Technical Document Abbreviated New Drug Application Center for Tobacco Products Health Canada Medicine Food and Drug Administration Clinical research

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