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Electronic common technical document
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#	Item
381	Specification for Transmitting Electronic Submissions using eCTD Backbone Specifications Add to Reading List Source URL: www.fda.gov Language: English Clinical Data Management Clinical research Medical informatics Electronic Common Technical Document Clinical Data Interchange Standards Consortium Image file formats Common Technical Document File format Scalable Vector Graphics Computing Computer file formats Graphics file formats
382	PDF Document Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2014-07-02 12:31:12 Pharmaceutical sciences Pharmaceutical industry Pharmaceuticals policy Drug safety Food and Drug Administration Clinical trial Regulatory requirement Electronic Common Technical Document Good manufacturing practice Clinical research Research Health
383	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Clinical Data Management Food and Drug Administration Drug safety Pharmaceutical industry Electronic Common Technical Document Investigational New Drug New Drug Application Common Technical Document Electronic submission Research Clinical research Medicine
384	PDF Document Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-06-24 11:44:53 Pharmaceutical industry Health Canada Medical informatics Electronic Common Technical Document Common Technical Document Health Products and Food Branch Clinical Data Management Research Clinical research
385	CTD General Q&As June[removed] Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:07:22 Health Clinical Data Management Medical informatics Pharmaceuticals policy Pharmaceutical industry Electronic Common Technical Document Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Marketing authorization Clinical research Medicine Research
386	eStability Implementation Guide 1.0 Add to Reading List Source URL: www.fda.gov Language: English Health Level 7 Electronic Common Technical Document Object identifier XML SQL HTML International HL7 Implementations Structured Product Labeling Computing Medical informatics Health
387	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
388	DRUG MASTER FILES UNDER GDUFA: DMF Basics Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Medicine Health Clinical research Drug Master File Drug safety Electronic Common Technical Document New Drug Application Prescription Drug User Fee Act Pharmaceuticals policy Pharmaceutical industry Food and Drug Administration
389	Guidance for Industry E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmacology Drug discovery Pharmaceutical industry Clinical Data Management Biomarker Electronic Common Technical Document Proteomics International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Medicine Biology Research
390	Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning Add to Reading List Source URL: www.fda.gov Language: English Science Food and Drug Administration Design of experiments Evaluation methods Pharmacology Electronic Common Technical Document Clinical trial Placebo-controlled study Investigational New Drug Research Clinical research Medicine

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