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1. Full Text Prescriber Patterns of SGLT2i After Expansions of U.S. Food and Drug Administration Labeling
by Vaduganathan, Muthiah and Sathiyakumar, Vasanth and Singh, Avinainder and McCarthy, Cian P and Qamar, Arman and Januzzi, James L and Scirica, Benjamin M and Butler, Javed and Cannon, Christopher P and Bhatt, Deepak L
Journal of the American College of Cardiology, ISSN 0735-1097, 12/2018, Volume 72, Issue 25, pp. 3370 - 3372
Empagliflozin was shown to reduce risk of cardiovascular death among high-risk patients with type 2 diabetes mellitus (1), which led to the U.S. Food and Drug... 
CARDIAC & CARDIOVASCULAR SYSTEMS | Hypoglycemic Agents - therapeutic use | Sodium-Glucose Transporter 2 Inhibitors - therapeutic use | United States | Cardiovascular Diseases - drug therapy | Humans | Middle Aged | Drug Labeling - trends | Male | Drug Prescriptions | United States Food and Drug Administration - legislation & jurisprudence | Drug Labeling - legislation & jurisprudence | Tertiary Care Centers - legislation & jurisprudence | Cardiovascular Diseases - epidemiology | Tertiary Care Centers - trends | Female | Aged | Retrospective Studies | United States Food and Drug Administration - trends | Regulatory agencies | Peptides | Risk groups | Diabetes mellitus | Health risks | Risk reduction | Labelling | Risk | FDA approval | Regulatory approval | Diabetes | Risk management | Cardiovascular diseases | Labeling | Cardiology | Prescriptions | Diabetes mellitus (non-insulin dependent) | Endocrinology | Food
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2. 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, 02/2014, Volume 168, Issue 2, pp. 130 - 136
IMPORTANCE Federal legislation has led to a notable increase in pediatric studies submitted to the Food and Drug Administration (FDA), resulting in new... 
GASTROESOPHAGEAL-REFLUX | PHARMACOKINETICS | INTENSIVE-CARE-UNIT | INFANTS | VENTRICULAR TACHYARRHYTHMIA | PREGNANT-WOMEN | PEDIATRICS | RANDOMIZED MULTICENTER | OFF-LABEL | INHALED NITRIC-OXIDE | PEDIATRIC POPULATION | Infant, Newborn, Diseases - drug therapy | Drug Labeling - legislation & jurisprudence | Pediatrics | 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 | FDA | neonate | drugs | labeling | medications
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3. 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
Pharmacometric analyses have become an increasingly important component of New Drug Application (NDA) and Biological License Application (BLA) submissions to... 
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 | PEDIATRICS | PHARMACOLOGY & PHARMACY | 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
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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, ISSN 0098-7484, 08/2003, Volume 290, Issue 7, pp. 905 - 911
CONTEXT Approximately 50% to 75% of drugs used in pediatric medicine have not been studied adequately to provide appropriate labeling information. In 1997,... 
MEDICINE, GENERAL & INTERNAL | CHILDREN | 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
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5. 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
Congress has modified regulations of the Food and Drug Administration to promote research assessing the efficacy and safety of drugs in children. The authors... 
MEDICINE, GENERAL & INTERNAL | INFORMATION | Drugs | Medical law | Care and treatment | Children | Pediatric research | Laws, regulations and rules
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6. 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
The FDA's proposals for revising its Nutrition Facts label for foods are strong, urgently needed, and likely to affect consumer behavior positively. But... 
MEDICINE, GENERAL & INTERNAL | 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
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7. Full Text Adolescent Dosing and Labeling Since the Food and Drug Administration Amendments Act of 2007
by Momper, Jeremiah D and Mulugeta, Yeruk and Green, Dionna J and Karesh, Alyson and Krudys, Kevin M and Sachs, Hari C and Yao, Lynn P and Burckart, Gilbert J
JAMA Pediatrics, ISSN 2168-6203, 10/2013, Volume 167, Issue 10, pp. 926 - 932
IMPORTANCE During pediatric drug development, dedicated pharmacokinetic studies are generally performed in all relevant age groups to support dose selection... 
CLEARANCE | PEDIATRICS | PHARMACOKINETICS | CHILDREN | PREDICTION | AGE | Body Weight | United States | Humans | Drug Labeling - statistics & numerical data | Male | Metabolic Clearance Rate | Drug Approval - legislation & jurisprudence | Drug Labeling - legislation & jurisprudence | Models, Biological | Adolescent | Adult | Female | Pharmaceutical Preparations - administration & dosage | Pharmacokinetics | United States Food and Drug Administration
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8. Full Text Front-of-Package Nutrition Labeling — An Abuse of Trust by the Food Industry?
by Brownell, Kelly D and Koplan, Jeffrey P
The New England Journal of Medicine, ISSN 0028-4793, 06/2011, Volume 364, Issue 25, pp. 2373 - 2375
On January 24, two food-industry trade associations announced a new voluntary nutrition-labeling system that major food and beverage companies would use on the... 
MEDICINE, GENERAL & INTERNAL | Food Industry | Food Labeling - methods | Public Health | Nutritive Value | United States | Humans | Food Labeling - legislation & jurisprudence | United States Food and Drug Administration | Consumer protection | Food labeling | Management | Beverage industry | Laws, regulations and rules | Public health | Obesity | Nutrition | Abuse | Food industry | Nutrients | Labeling | Vitamins | Food
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9. Full Text Labelling of electronic cigarettes: regulations and current practice
by Buonocore, Federico and Marques Gomes, Ana C N and Nabhani-Gebara, Shereen and Barton, Stephen J and Calabrese, Gianpiero
Tobacco Control, ISSN 0964-4563, 01/2017, Volume 26, Issue 1, pp. 46 - 52
BackgroundOver the past decade e-cigarettes have established themselves in the global market. E-cigarettes triggered much interest in relation to their content... 
RATS | PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH | SMOKING | NICOTINE | EXPRESSION | Product Labeling - legislation & jurisprudence | Drug Packaging - legislation & jurisprudence | European Union | Electronic Nicotine Delivery Systems | Humans | Government Regulation | United Kingdom | Laws, regulations and rules | Electronic cigarettes | Analysis | Environmental protection | Index Medicus | Electronic nicotine delivery devices | Environment | Research Paper | 1506 | Nicotine
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10. Full Text The Unknowns and Possible Implications of Mandatory Labeling
by McFadden, Brandon R
Trends in Biotechnology, ISSN 0167-7799, 2016, Volume 35, Issue 1, pp. 1 - 3
The National Bioengineered Food Disclosure Standard requires a mandatory label for genetically modified (GM) food. Currently, some aspects of the bill are... 
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 | Legislation | Chromium | Labels | Foods | Trends | Standards | Genetic modification
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11. 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
The Patient Protection and Affordable Care Act requires establishments with 20 or more locations nationwide to post calorie counts along with a succinct... 
MEDICINE, GENERAL & INTERNAL | 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
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12. Full Text The new FDA labeling rule: impact on prescribing rheumatological medications during pregnancy
by Bermas, Bonnie L and Tassinari, Melissa and Clowse, Megan and Chakravarty, Eliza
Rheumatology, ISSN 1462-0324, 07/2018, Volume 57, Issue suppl_5, pp. v2 - v8
Abstract After several decades of deliberation, the US Food and Drug Administration updated the Pregnancy and Lactation Labeling Rule in 2015, eliminating the... 
RHEUMATOID-ARTHRITIS | SYSTEMIC-LUPUS-ERYTHEMATOSUS | RISK-FACTORS | systematic lupus erythematosus | pregnancy | AZATHIOPRINE | RHEUMATOLOGY | rheumatoid arthritis | DISEASE-ACTIVITY | HYDROXYCHLOROQUINE | WOMEN | DISPARITIES | FDA labelling | OUTCOMES | ANTIRHEUMATIC DRUGS | Risk Assessment - methods | Rheumatic Diseases - drug therapy | United States | Humans | Risk Assessment - legislation & jurisprudence | United States Food and Drug Administration - legislation & jurisprudence | Pregnancy Complications - drug therapy | Pregnancy | Drug Labeling - legislation & jurisprudence | Maternal Exposure - legislation & jurisprudence | Antirheumatic Agents - adverse effects | Female | Drug Labeling - methods | Cost-benefit analysis | Lactation | Reviews
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13. Full Text National Menu Labeling
by Fly, Alyce D., PhD
Journal of Nutrition Education and Behavior, ISSN 1499-4046, 2017, Volume 49, Issue 4, pp. 273 - 273
Internal Medicine | Gastroenterology and Hepatology | EDUCATION, SCIENTIFIC DISCIPLINES | NUTRITION & DIETETICS | Food Labeling - standards | Nutritive Value | United States | Humans | Food Labeling - legislation & jurisprudence | Menu Planning | United States Food and Drug Administration
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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 & Therapeutics, ISSN 0009-9236, 02/2007, Volume 81, Issue 2, pp. 213 - 221
Exploratory analyses of data pertaining to pharmacokinetic, pharmacodynamic, and disease progression are often referred to as the pharmacometrics (PM)... 
PHARMACOLOGY & PHARMACY | EXPERIENCE | 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
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15. Full Text Recent Changes in Pregnancy and Lactation Labeling: Retirement of Risk Categories
by Ramoz, Leda L and Patel‐Shori, Nima M
Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, ISSN 0277-0008, 04/2014, Volume 34, Issue 4, pp. 389 - 395
The rapid development and increased availability of novel pharmacologic therapies and pharmaceutical products has amplified the potential for drug exposure... 
U.S. Food and Drug Administration | FDA | risk categories | lactation | labeling | pregnancy | DRUGS | PHARMACOLOGY & PHARMACY | BREAST-MILK | EXPOSURE | Fetus - drug effects | Pregnancy | Drug Labeling - legislation & jurisprudence | United States | Humans | Lactation - drug effects | Female | Risk | United States Food and Drug Administration | Pregnant women | Pharmaceutical industry | Labeling
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16. Full Text Summaries of safety labeling changes approved by FDA—Boxed warnings highlights October-December 2015
and Office of Health & Constituent Affairs U.S. Food and Drug AdministrationOffice of Health & Constituent Affairs, U.S. Food and Drug Administration
American Journal of Health-System Pharmacy, ISSN 1079-2082, 03/2016, Volume 73, Issue 5, pp. 267 - 267
PHARMACOLOGY & PHARMACY | Drug Labeling - legislation & jurisprudence | Methotrexate - adverse effects | Drug-Related Side Effects and Adverse Reactions - prevention & control | United States | Humans | United States Food and Drug Administration - standards | Drug Labeling - trends | United States Food and Drug Administration - trends | Drug Labeling - standards | United States Food and Drug Administration - legislation & jurisprudence | Laws, regulations and rules | Patient package inserts
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17. Full Text A Proactive Response to Prescription Opioid Abuse
by Califf, Robert M and Woodcock, Janet and Ostroff, Stephen
The New England Journal of Medicine, ISSN 0028-4793, 04/2016, Volume 374, Issue 15, pp. 1480 - 1485
The FDA has committed to working with other agencies, health care providers, industry, and patients and families to deal proactively with the opioid abuse... 
MEDICINE, GENERAL & INTERNAL | Drug Labeling - legislation & jurisprudence | United States | Humans | Pain Management - methods | Analgesics, Opioid - therapeutic use | Opioid-Related Disorders - prevention & control | Prescription Drug Misuse - prevention & control | Drug and Narcotic Control | Prescription Drug Misuse - legislation & jurisprudence | United States Food and Drug Administration | Medical care | Care and treatment | Management | Health aspects | Patients | Prescription drugs | Drug abuse | Pain | Abuse | Narcotics | Pain management | Opioids | Addictions | Public health
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