Electronic common technical document

Results: 446



#Item
321Clinical research / Clinical Data Management / Food and Drug Administration / Drug safety / Electronic Common Technical Document / Health Level 7 / Prescription Drug User Fee Act / Medical device / Regulated Product Submissions / Medicine / Health / Medical informatics

Microsoft PowerPoint - 281_Gray.ppt [Compatibility Mode]

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Source URL: www.fda.gov

Language: English
322Pharmacology / Medical informatics / Competitions / Digital media / Food and Drug Administration / Electronic submission / Electronic Common Technical Document / Clinical research / Research / Pharmaceutical sciences

Draft Module 1 Update[removed]Promotional Materials) Marci Kiester, Pharm D CDR, USPHS

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Source URL: www.fda.gov

Language: English
323Medical informatics / Clinical Data Management / Food and Drug Administration / Electronic Common Technical Document / Electronic submission / Center for Biologics Evaluation and Research / Regulated Product Submissions / Medicine / Research / Clinical research

Presentation Slide Template (DIA)

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Source URL: www.fda.gov

Language: English
324Food and Drug Administration / Health / Clinical Data Management / Pharmaceutical industry / Medical informatics / Electronic Common Technical Document / Title 21 CFR Part 11 / Center for Drug Evaluation and Research / Validation / Medicine / Research / Clinical research

FDA Considerations for eCTD INDs

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Source URL: www.fda.gov

Language: English
325Drug Information Association / Microsoft PowerPoint / Electronic Common Technical Document / Dia / HTML element / Software / Computing / Clinical research

If you need to change an indication

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Source URL: www.fda.gov

Language: English
326Medicine / Medical informatics / Electronic Common Technical Document / Competitions / Digital media / Electronic submission / Food and Drug Administration / Research / Clinical research / Clinical Data Management

Microsoft PowerPoint - Roeder_Dave_RPM perspective_V2.ppt [Compatibility Mode]

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Source URL: www.fda.gov

Language: English
327Pharmaceutical sciences / Medical informatics / Pharmaceutical industry / Electronic Common Technical Document / Digital media / Validation / Food and Drug Administration / Electronic submission / Investigational New Drug / Clinical research / Research / Clinical Data Management

Microsoft PowerPoint[removed]Gensinger.ppt

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Source URL: www.fda.gov

Language: English
328Clinical research / Medicine / Electronic Common Technical Document / Clinical Data Interchange Standards Consortium / Structured Product Labeling / Common Technical Document / Electronic submission / Food and Drug Administration / Clinical Data Management / Medical informatics / Research

CDER Update eCTD & Gateway Submissions Virginia Ventura Team Lead, Electronic Submission Support Office of Business Informatics

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Source URL: www.fda.gov

Language: English
329Research / Clinical research / Food and Drug Administration / Clinical Data Management / Standards organizations / Electronic Common Technical Document / Clinical Data Interchange Standards Consortium / Prescription Drug User Fee Act / SDTM / Medicine / Health / Medical informatics

Microsoft PowerPoint[removed]Gary Gensinger.ppt [Compatibility Mode]

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Source URL: www.fda.gov

Language: English
330Electronic documents / Computing / Clinical Data Management / Medical informatics / AS2 / Electronic submission / Electronic Common Technical Document / Food and Drug Administration / Email / Cryptography / Clinical research / Research

Microsoft PowerPoint - Gateway and Validation1.ppt

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Source URL: www.fda.gov

Language: English
UPDATE