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1. Full Text Promoting Pediatric Drug Research and Labeling — Outcomes of Legislation
by Bourgeois, Florence T and Kesselheim, Aaron S
The New England journal of medicine, ISSN 0028-4793, 08/2019, Volume 381, Issue 9, pp. 875 - 881
Medicine, General & Internal | Life Sciences & Biomedicine | General & Internal Medicine | Science & Technology | Drugs | Medical law | Care and treatment | Children | Pediatric research | Laws, regulations and rules | Hypertension | Prescription drugs | Pediatrics | Descriptive labeling | Legislation | Clinical trials | FDA approval | Drug development | Pharmaceuticals | Index Medicus | Abridged Index Medicus
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2. Full Text Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions
: A Review of 198 Submissions Between 2000 and 2008
by Lee, Joo Yeon and Garnett, Christine E and Gobburu, Jogarao V. S and Bhattaram, Venkatesh A and Brar, Satjit and Earp, Justin C and Jadhav, Pravin R and Krudys, Kevin and Lesko, Lawrence J and Li, Fang and Liu, Jiang and Madabushi, Rajnikanth and Marathe, Anshu and Mehrotra, Nitin and Tornoe, Christoffer and Wang, Yaning and Zhu, Hao
Clinical pharmacokinetics, ISSN 0312-5963, 10/2011, Volume 50, Issue 10, pp. 627 - 635
Pharmacotherapy | Internal Medicine | Medicine & Public Health | Pharmacology/Toxicology | Dose-prediction | Pharmacodynamic-modelling | Population-pharmacokinetics | Product-approvals | Clinical-trial-design | Labelling | Pharmacokinetic-pharmacodynamic-relationships | Pharmacokinetic-modelling | Regulatory-process | Life Sciences & Biomedicine | Pharmacology & Pharmacy | Science & Technology | Biological and medical sciences | Medical sciences | General pharmacology | Pharmacology. Drug treatments | Pharmacokinetics. Pharmacogenetics. Drug-receptor interactions | United States | Humans | Decision Support Techniques | Drugs, Investigational - pharmacokinetics | Drug Labeling - statistics & numerical data | Clinical Trials as Topic | Drug Labeling - standards | Dose-Response Relationship, Drug | Drug Labeling - legislation & jurisprudence | Models, Biological | Investigational New Drug Application - legislation & jurisprudence | Drugs, Investigational - administration & dosage | Investigational New Drug Application - statistics & numerical data | Investigational New Drug Application - methods | Drug Labeling - methods | United States Food and Drug Administration | Index Medicus
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3. Full Text The Calorie-Labeling Saga — Federal Preemption and Delayed Implementation of Public Health Law
by Block, Jason P
The New England journal of medicine, ISSN 0028-4793, 07/2018, Volume 379, Issue 2, pp. 103 - 105
Medicine, General & Internal | Life Sciences & Biomedicine | General & Internal Medicine | Science & Technology | State Government | Local Government | Time Factors | United States | Food Labeling - legislation & jurisprudence | Government Regulation | Lobbying | Public Health - legislation & jurisprudence | Energy Intake | Patient Protection and Affordable Care Act | United States Food and Drug Administration | Laws, regulations and rules | Food industry | Food labeling | Retail stores | Obesity | Health care policy | Consumers | Federal regulation | Public interest | Disclosure | Restaurants | Local elections | Pizza | Enforcement | Government agencies | Price, Tom | Food chains | Gottlieb, Scott | Labeling | Public health | Food | Smoking | Index Medicus | Abridged Index Medicus
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4. Full Text Pediatric Drug Labeling: Improving the Safety and Efficacy of Pediatric Therapies
by Roberts, Rosemary and Rodriguez, William and Murphy, Dianne and Crescenzi, Terrie
JAMA : the journal of the American Medical Association, ISSN 0098-7484, 08/2003, Volume 290, Issue 7, pp. 905 - 911
Medicine, General & Internal | Life Sciences & Biomedicine | General & Internal Medicine | Science & Technology | Public health. Hygiene-occupational medicine | Public health. Hygiene | Biological and medical sciences | Medical sciences | Pharmaceutical industries | United States | Humans | Child, Preschool | Infant | Treatment Outcome | Drug Labeling - standards | Drug Labeling - legislation & jurisprudence | Drug Therapy - standards | Adolescent | Pediatrics - standards | Safety | Child | Infant, Newborn | Marketing - legislation & jurisprudence | United States Food and Drug Administration | Pediatric pharmacology | Laws, regulations and rules | Drugs | Labeling | Federal regulation | Index Medicus | Abridged Index Medicus
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5. Full Text Drug Labeling and Exposure in Neonates
by Laughon, Matthew M and Avant, Debbie and Tripathi, Nidhi and Hornik, Christoph P and Cohen-Wolkowiez, Michael and Clark, Reese H and Smith, P. Brian and Rodriguez, William
JAMA pediatrics, ISSN 2168-6203, 12/2013, Volume 168, Issue 2, pp. 130 - 136
Life Sciences & Biomedicine | Pediatrics | Science & Technology | Infant, Newborn, Diseases - drug therapy | Drug Labeling - legislation & jurisprudence | United States - epidemiology | Intensive Care Units, Neonatal | Humans | Drug Labeling - statistics & numerical data | Infant, Newborn | United States Food and Drug Administration | Patient package inserts | Infants | Information management | Health aspects | Index Medicus | Abridged Index Medicus | FDA | neonate | drugs | labeling | medications
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6. Full Text Health Care Reform in Action — Calorie Labeling Goes National
by Nestle, Marion
The New England journal of medicine, ISSN 0028-4793, 06/2010, Volume 362, Issue 25, pp. 2343 - 2345
Medicine, General & Internal | Life Sciences & Biomedicine | General & Internal Medicine | Science & Technology | Health Care Reform | Food Labeling - standards | Nutritive Value | United States | Humans | Obesity - prevention & control | Food Labeling - legislation & jurisprudence | Energy Intake | Restaurants - legislation & jurisprudence | United States Food and Drug Administration | Restaurants - standards | Prevention | Obesity | Control | Laws, regulations and rules | Chain restaurants | Health care reform | Food labeling | Stores | Studies | Descriptive labeling | Diet | Nutrition | Health care policy | Public interest | Labeling | Restaurants | Index Medicus | Abridged Index Medicus
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7. Full Text Toward More Comprehensive Food Labeling
by Kessler, David A
The New England journal of medicine, ISSN 0028-4793, 07/2014, Volume 371, Issue 3, pp. 193 - 195
Medicine, General & Internal | Life Sciences & Biomedicine | General & Internal Medicine | Science & Technology | Nutrition Policy - legislation & jurisprudence | Food Labeling - standards | Nutritive Value | United States | Humans | Food Labeling - legislation & jurisprudence | United States Food and Drug Administration | Natural foods | Obesity | Control | Food labeling | Analysis | Standards | Consumer behavior | Descriptive labeling | Nutrition | Proposals | Sugar | Food | Index Medicus | Abridged Index Medicus
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8. Full Text Consistency in the safety labeling of bioequivalent medications
by Duke, Jon and Friedlin, Jeff and Li, Xiaochun
Pharmacoepidemiology and drug safety, ISSN 1053-8569, 03/2013, Volume 22, Issue 3, pp. 294 - 301
drug labeling | generic medications | adverse reactions | drug safety | pharmacoepidemiology | Pharmacoepidemiology | Generic medications | Adverse reactions | Drug safety | Drug labeling | Pharmacology & Pharmacy | Public, Environmental & Occupational Health | Life Sciences & Biomedicine | Science & Technology | Biological and medical sciences | Medical sciences | General pharmacology | Clinical trial. Drug monitoring | Pharmacology. Drug treatments | Adverse Drug Reaction Reporting Systems - legislation & jurisprudence | Guidelines as Topic | Adverse Drug Reaction Reporting Systems - standards | Risk Assessment | United States | Drug Industry - legislation & jurisprudence | Humans | Risk Factors | United States Food and Drug Administration - standards | Natural Language Processing | Drug Labeling - standards | United States Food and Drug Administration - legislation & jurisprudence | Drug Labeling - legislation & jurisprudence | Drugs, Generic - adverse effects | Guideline Adherence | Patient Safety | Drug and Narcotic Control - legislation & jurisprudence | Drug Industry - standards | Therapeutic Equivalency | Drugs | Labels | Structured notes (Securities) | Analysis | Prescription drugs | Federal regulation | Descriptive labeling | Safety | Index Medicus
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9. Full Text The Unknowns and Possible Implications of Mandatory Labeling
by McFadden, Brandon R
Trends in biotechnology (Regular ed.), ISSN 0167-7799, 2016, Volume 35, Issue 1, pp. 1 - 3
Internal Medicine | GM foods | mandatory labeling | food value chain | Mandatory labeling | Food value chain | Consumer Product Safety - legislation & jurisprudence | Food Labeling - standards | Public Opinion | United States | Consumer Product Safety - standards | Food Labeling - legislation & jurisprudence | Government Regulation | Food, Genetically Modified - standards | United States Food and Drug Administration | Biotechnology | Genetically engineered foods | Genetically modified organisms | Food | Food labeling | Consumption | Descriptive labeling | Cost estimates | Value chain | Consumers | Ingredients | Science | Federal legislation | Deoxyribonucleic acid--DNA | Index Medicus | Legislation | Chromium | Labels | Foods | Trends | Standards | Genetic modification
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10. Full Text Development of the epiocular™ eye irritation test for hazard identification and labelling of eye irritating chemicals in response to the requirements of the EU cosmetics directive and REACH legislation
by Kaluzhny, Yulia and Kandárová, Helena and Hayden, Patrick and Kubilus, Joseph and D'Argembeau-Thornton, Laurence and Klausner, Mitchell
Alternatives to laboratory animals, ISSN 0261-1929, 09/2011, Volume 39, Issue 4, pp. 339 - 364
REACH | Validation | EpiOcular | ECVAM | Reconstructed ocular tissue model | In vitro | Eye irritation | Life Sciences & Biomedicine | Medicine, Research & Experimental | Science & Technology | Research & Experimental Medicine | Biological and medical sciences | Toxicology | Medical sciences | Domestic and cosmetic products toxicology | Product Labeling | Animal Testing Alternatives | Humans | Cosmetics | Toxicity Tests - methods | Eye - drug effects | Irritants - toxicity | Quality Control | Index Medicus
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11. Truth in research labelling
by Noble, John H
Indian journal of medical ethics, 07/2017, Volume 2, Issue 3, pp. 194 - 199
Biomedical Research - ethics | United States | Deception | Humans | Randomized Controlled Trials as Topic - ethics | Randomized Controlled Trials as Topic - legislation & jurisprudence | Publishing - legislation & jurisprudence | Fraud | Disclosure | Evidence-Based Medicine | Ethics, Research | United States Food and Drug Administration - legislation & jurisprudence | Biomedical Research - legislation & jurisprudence | United States Food and Drug Administration - ethics | Legislation, Medical | Editorial Policies | Government Regulation | Publishing - ethics | Research Report - legislation & jurisprudence | Ethical Theory
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12. Full Text Tobacco Packaging and Labeling Policies Under the U.S. Tobacco Control Act: Research Needs and Priorities
by Hammond, David
Nicotine & tobacco research, ISSN 1462-2203, 2012, Volume 14, Issue 1, pp. 62 - 74
Public, Environmental & Occupational Health | Life Sciences & Biomedicine | Substance Abuse | Science & Technology | United States | Humans | Product Packaging - legislation & jurisprudence | Product Packaging - standards | Smoking - legislation & jurisprudence | Disclosure - legislation & jurisprudence | Research | Smoking Prevention | Tobacco | Tobacco Industry - economics | Drug and Narcotic Control - legislation & jurisprudence | Government Regulation | Tobacco Industry - legislation & jurisprudence | Consumer Health Information | Disclosure - standards | United States Food and Drug Administration | Index Medicus | Themed Section
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13. Full Text Single cigarette sales: State Differences in FDA Advertising and Labeling Violations, 2014, United States
by Baker, Hannah M and Lee, Joseph G.L and Ranney, Leah M and Goldstein, Adam O
Nicotine & tobacco research, ISSN 1462-2203, 02/2016, Volume 18, Issue 2, pp. 221 - 226
Public, Environmental & Occupational Health | Life Sciences & Biomedicine | Substance Abuse | Science & Technology | Commerce - economics | United States - epidemiology | Advertising as Topic - economics | Advertising as Topic - legislation & jurisprudence | Cross-Sectional Studies | Humans | Male | Smoking - legislation & jurisprudence | Product Labeling - economics | Taxes - legislation & jurisprudence | United States Food and Drug Administration - legislation & jurisprudence | Product Labeling - legislation & jurisprudence | Tobacco Industry - economics | Smoking - epidemiology | Tobacco Products - economics | Adolescent | Female | Tobacco Industry - legislation & jurisprudence | Marketing - economics | Marketing - legislation & jurisprudence | Taxes - economics | Commerce - legislation & jurisprudence | Index Medicus | Brief Report
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14. Full Text Impact of Pharmacometric Reviews on New Drug Approval and Labeling Decisions-a Survey of 31 New Drug Applications Submitted Between 2005 and 2006
by Bhattaram, V A and Bonapace, C and Chilukuri, D M and Duan, J Z and Garnett, C and Gobburu, J V S and Jang, S H and Kenna, L and Lesko, L J and Madabushi, R and Men, Y and Powell, J R and Qiu, W and Ramchandani, R P and Tornoe, C W and Wang, Y and Zheng, J J
Clinical pharmacology and therapeutics, ISSN 0009-9236, 02/2007, Volume 81, Issue 2, pp. 213 - 221
Life Sciences & Biomedicine | Pharmacology & Pharmacy | Science & Technology | Biological and medical sciences | Pharmacology. Drug treatments | Medical sciences | Drug Evaluation - methods | Lipoproteins - therapeutic use | Quinoxalines - adverse effects | Risk Assessment - methods | United States | Benzazepines - adverse effects | Humans | United States Food and Drug Administration - standards | Varenicline | Cyclosporins - administration & dosage | Data Collection | Peptides, Cyclic - administration & dosage | United States Food and Drug Administration - legislation & jurisprudence | Drug Labeling - legislation & jurisprudence | Cyclosporins - therapeutic use | Investigational New Drug Application - legislation & jurisprudence | Everolimus | Sirolimus - adverse effects | Lipoproteins - adverse effects | Quinoxalines - therapeutic use | Sirolimus - analogs & derivatives | Sirolimus - therapeutic use | Drug Administration Schedule | Peer Review | Quinoxalines - administration & dosage | Cyclosporins - adverse effects | Decision Support Techniques | Pharmacology, Clinical | Treatment Outcome | Disease Progression | Drug Approval - legislation & jurisprudence | Sirolimus - administration & dosage | Lipoproteins - administration & dosage | Benzazepines - therapeutic use | Echinocandins | Investigational New Drug Application - statistics & numerical data | Peptides, Cyclic - therapeutic use | Benzazepines - administration & dosage | Clinical Trials as Topic - methods | Pharmacokinetics | Lipopeptides | Peptides, Cyclic - adverse effects | Index Medicus | Abridged Index Medicus
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