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Structured Product Labeling
Results: 235

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51	Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS) Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmacy Food and Drug Administration Pharmaceuticals policy Medical informatics Prescription Drug User Fee Act Structured Product Labeling Pharmacovigilance Electronic prescribing Medicine Health Pharmaceutical sciences
52	Guidance for Industry Electronic Submission of Lot Distribution Reports DRAFT GUIDANCE This guidance document is for comment purposes only. Submit one set of either electronic or written comments on this draft guidance b Add to Reading List Source URL: www.fda.gov Language: English Research Structured Product Labeling Center for Biologics Evaluation and Research Adverse Event Reporting System Validation Electronic Common Technical Document Federal Food Drug and Cosmetic Act Abbreviated New Drug Application Title 21 CFR Part 11 Food and Drug Administration Medicine Health
53	The GUDID Account January 30, 2014 Indira R. Konduri GUDID Program Manager Add to Reading List Source URL: www.fda.gov Language: English Unique Device Identification Medical device Center for Devices and Radiological Health Structured Product Labeling Medicine Food and Drug Administration Health
54	Enhancing the National Drug File – Reference Terminology (NDF-RT) for Meaningful Use The Veterans Health Administration (VHA) National Drug File – Reference Terminology (NDF-RT) is a medication reference terminology Add to Reading List Source URL: evs.nci.nih.gov Language: English - Date: 2014-09-23 13:04:35 Medical informatics International standards Nursing informatics Electronic health record Structured Product Labeling Food and Drug Administration Daily Med Health information technology Alternative medicine Health Medicine Health informatics
55	Guidance for Industry Electronic Submission of Lot Distribution Reports DRAFT GUIDANCE This guidance document is for comment purposes only. Submit one set of either electronic or written comments on this draft guidance b Add to Reading List Source URL: www.fda.gov Language: English Research Structured Product Labeling Center for Biologics Evaluation and Research Adverse Event Reporting System Validation Electronic Common Technical Document Federal Food Drug and Cosmetic Act Abbreviated New Drug Application Title 21 CFR Part 11 Food and Drug Administration Medicine Health
56	Report to Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce Report on Study Commitment Regarding Inclusion of Toll-Free Adverse Event Reporting Number by FDA Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical sciences Clinical pharmacology Therapeutics United States Public Health Service MedWatch Adverse effect Direct-to-consumer advertising Structured Product Labeling Medicine Food and Drug Administration Health
57	DRLS Small Business Chronicles Add to Reading List Source URL: www.fda.gov Language: English Health Food and Drug Administration Pharmacology Food law Pharmaceutical industry Structured Product Labeling National Drug Code Dietary supplement Abbreviated New Drug Application Medicine Pharmaceutical sciences Pharmaceuticals policy
58	Guidance for Industry and FDA Staff Add to Reading List Source URL: www.fda.gov Language: English Health Center for Devices and Radiological Health Title 21 CFR Part 11 Structured Product Labeling Food and Drug Administration Pharmaceutical sciences Medicine
59	DEPARTMENT OF HFALTH Our STN: BL[removed]Sally Gould Add to Reading List Source URL: www.fda.gov Language: English Medicine Immunosuppressants Clinical pharmacology United States Public Health Service Etanercept Biologic Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Structured Product Labeling Food and Drug Administration Biotechnology Pharmacology
60	http://www.fda.gov/CDER/foi/appletter/2002/urokabb101002L.htm Add to Reading List Source URL: www.fda.gov Language: English Health Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Biologic Federal Food Drug and Cosmetic Act New Drug Application Adverse Event Reporting System Structured Product Labeling Food and Drug Administration Medicine Pharmaceutical sciences

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