Structured Product Labeling

Results: 235



#Item
151Pharmaceutical industry / Medical informatics / Food and Drug Administration / Anticonvulsants / New Drug Application / Phenytoin / Package insert / Structured Product Labeling / Prescription medication / Medicine / Pharmaceutical sciences / Pharmacology

Template Letter to Sponsors

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Source URL: www.fda.gov

Language: English
152Food law / Pharmaceutical sciences / Pharmaceuticals policy / Pharmacology / Therapeutics / Structured Product Labeling / Federal Food /  Drug /  and Cosmetic Act / Center for Drug Evaluation and Research / Generic drug / Medicine / Health / Food and Drug Administration

Microsoft PowerPoint - Labeling Updates.ppt

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Source URL: www.fda.gov

Language: English
153Pharmaceutical sciences / Medical informatics / Pharmaceutical industry / Pharmaceuticals policy / United States Public Health Service / Structured Product Labeling / New Drug Application / Federal Food /  Drug /  and Cosmetic Act / Package insert / Medicine / Food and Drug Administration / Health

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring, MD[removed]NDA[removed]NDA APPROVAL

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Source URL: www.accessdata.fda.gov

Language: English - Date: 2014-04-03 11:09:13
154Pharmaceutical sciences / Federal Food /  Drug /  and Cosmetic Act / Abbreviated New Drug Application / Unique Device Identification / Structured Product Labeling / Food and Drug Administration / Medicine / Health

[removed]Federal Register / Vol. 79, No[removed]Wednesday, April 2, [removed]Notices process, draft recommendations are posted on FDA’s Web site and

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Source URL: www.gpo.gov

Language: English - Date: 2014-04-03 10:01:10
155Structured Product Labeling / Markup languages / Form / HTML / Internet Explorer / Computing / Software / XForms

Preparing Electronic NDC Labeler Code and Drug Establishment Registration Submissions in SPL Format Version 1.0 Preface

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Source URL: www.fda.gov

Language: English
156Structured Product Labeling / XForms / Markup languages / Identifiers / Form / HTML / Globally unique identifier / Computing / Software / Web standards

Basic Instructions for Using the SPL Xforms Version 1.0 Preface •

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Source URL: www.fda.gov

Language: English
157Pharmaceutical sciences / Clinical research / Food law / Structured Product Labeling / New Drug Application / Daily Med / Federal Food /  Drug /  and Cosmetic Act / Antibacterial / Medicine / Food and Drug Administration / Health

Guidance for Industry Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices

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Source URL: www.fda.gov

Language: English
158Research / Clinical research / Pharmacology / Drug safety / New Drug Application / Validation / Center for Drug Evaluation and Research / Investigational New Drug / Structured Product Labeling / Pharmaceutical sciences / Food and Drug Administration / Pharmaceutical industry

Guidance for Industry Format and Content for the CMC Section of an Annual Report Center for Drug Evaluation and Research (CDER)

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Source URL: www.fda.gov

Language: English
159Pharmaceutical sciences / Prescription Drug User Fee Act / Center for Biologics Evaluation and Research / Center for Drug Evaluation and Research / Structured Product Labeling / Food and Drug Administration / Medicine / Health

TM, JKJ, EC, PJF, CJ, BY, KB

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Source URL: www.fda.gov

Language: English
160Pharmacology / Health / Prescription Drug User Fee Act / Pharmaceutical industry / New Drug Application / Criticism of the Food and Drug Administration / Structured Product Labeling / Food and Drug Administration / Pharmaceutical sciences / Pharmaceuticals policy

FDA-Industry PDUFA V Reauthorization Meeting

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Source URL: www.fda.gov

Language: English
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