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Electronic common technical document
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391	Guidance for Industry M2 eCTD: Electronic Common Technical Document Specification U.S. Department of Health and Human Services Add to Reading List Source URL: www.fda.gov Language: English Research Medical informatics Electronic Common Technical Document Markup languages Technical communication Regulated Product Submissions Computing Clinical Data Management Clinical research
392	Guidance for Industry M4S: August 2001 ICH Add to Reading List Source URL: www.fda.gov Language: English Clinical Data Management Food and Drug Administration Pharmacology Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical trial Electronic Common Technical Document Center for Biologics Evaluation and Research Research Clinical research Medicine
393	Guidance for Industry M4: The CTD - General Questions and Answers Add to Reading List Source URL: www.fda.gov Language: English Medicine Food and Drug Administration Pharmaceutical industry Health Drug safety 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 Research Clinical Data Management
394	Microsoft Word - 7042fnl.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Electronic Common Technical Document Drug safety Common Technical Document HTML element International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use HTML Food and Drug Administration Research Clinical research Clinical Data Management
395	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
396	Guidance for Industry Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications 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
397	Guidance for Industry M2: eCTD Specification Questions & Answers and Change Requests Add to Reading List Source URL: www.fda.gov Language: English Clinical Data Management Food and Drug Administration Drug safety Medical informatics Electronic Common Technical Document Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Medicine Research Clinical research
398	Guidance for Industry Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers U.S. Department of Health and Human Services Add to Reading List Source URL: www.fda.gov Language: English Health Adverse Event Reporting System Center for Biologics Evaluation and Research Electronic Common Technical Document Center for Drug Evaluation and Research Abbreviated New Drug Application Title 21 CFR Part 11 Structured Product Labeling Food and Drug Administration Medicine Clinical research
399	Guidance for Industry Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers U.S. Department of Health and Human Services Add to Reading List Source URL: www.fda.gov Language: English Health Adverse Event Reporting System Center for Biologics Evaluation and Research Electronic Common Technical Document Center for Drug Evaluation and Research Abbreviated New Drug Application Title 21 CFR Part 11 Structured Product Labeling Food and Drug Administration Medicine Clinical research
400	Guidance for Industry ANDA Submissions — Content and Format of Abbreviated New Drug Applications DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Research Clinical research Pharmaceuticals policy Clinical Data Management Abbreviated New Drug Application New Drug Application Electronic Common Technical Document Generic drug Food and Drug Administration Pharmaceutical industry Medicine

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