Structured Product Labeling

Results: 235



#Item
191Pharmaceutical industry / Pharmaceutical sciences / Food law / Pharmaceuticals policy / Clinical research / Structured Product Labeling / Title 21 CFR Part 11 / New Drug Application / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration / Medicine / Health

Guidance for Industry Providing Regulatory Submissions in Electronic Format Drug Establishment Registration and Drug Listing.

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Source URL: www.fda.gov

Language: English
192Health / 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

Guidance for Industry Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers U.S. Department of Health and Human Services

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Source URL: www.fda.gov

Language: English
193Food and Drug Administration / Pharmaceutical industry / Structured Product Labeling / Clinical research / Drug safety / New Drug Application / Center for Drug Evaluation and Research / Center for Biologics Evaluation and Research / Health Level 7 / Medicine / Medical informatics / Health

Microsoft Word - 7074fnl.doc

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Source URL: www.fda.gov

Language: English
194Pharmaceutical sciences / Medical informatics / Pharmaceutical industry / Structured Product Labeling / Clinical research / XForms / Validation / Center for Biologics Evaluation and Research / Medicine / Food and Drug Administration / Health

U.S. Food and Drug Administration Step-by-Step Instructions for Electronic Self-Identification of Facilities, Sites, and Organizations Generic Drug User Fee

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Source URL: www.fda.gov

Language: English
195Science / Structured Product Labeling / Information retrieval / Daily Med / Food and Drug Administration / Search engine indexing / Chemistry / Pharmaceutical industry / Information science / Pharmaceutical sciences / Pharmacology

I have a couple of comments as well

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Source URL: www.fda.gov

Language: English
196Medicine / Food and Drug Administration / Structured Product Labeling / Unique Ingredient Identifier / Pharmacology / Pharmaceutical sciences

Microsoft Word - IIG_FAQs_Final.doc

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Source URL: www.fda.gov

Language: English
197Medicine / Medical informatics / Pharmacology / Computer file formats / Electronic Common Technical Document / MedDRA / XML / Structured Product Labeling / HTML / Computing / Markup languages / Technical communication

5161 Specifications 508 FINAL Version 1.4.doc

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Source URL: www.fda.gov

Language: English
198Clinical pharmacology / Food and Drug Administration / Pharmacology / Therapeutics / United States Public Health Service / EPC / Structured Product Labeling / Pharmaceutical sciences / Medicine / Clinical research

Microsoft Word[removed]doc

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Source URL: www.fda.gov

Language: English
199Medicine / Center for Food Safety and Applied Nutrition / Food Safety Modernization Act / Center for Devices and Radiological Health / Structured Product Labeling / Food Safety and Modernization Act / Food and Drug Administration / Health / Pharmaceutical sciences

FDA’s Webpage Navigation and Online Regulatory Tutorials Christopher Jacquette

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Source URL: www.fda.gov

Language: English
200Pharmaceutical sciences / Personally identifiable information / New Drug Application / Internet privacy / Center for Drug Evaluation and Research / Adverse Event Reporting System / Privacy / Investigational New Drug / Structured Product Labeling / Food and Drug Administration / Medicine / Health

06.3 HHS PIA Summary for Posting (Form) / FDA CDER Adverse Event Reporting System [System] PIA SUMMARY AND APPROVAL COMBINED PIA Summary Is this a new PIA 2011? Yes If this is an existing PIA, please provide a reason for

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Source URL: www.hhs.gov

Language: English - Date: 2014-07-19 00:20:45
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