Download or read book Front of Package Nutrition Rating Systems and Symbols written by Institute of Medicine and published by National Academies Press. This book was released on 2012-01-30 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the past decade, tremendous growth has occurred in the use of nutrition symbols and rating systems designed to summarize key nutritional aspects and characteristics of food products. These symbols and the systems that underlie them have become known as front-of-package (FOP) nutrition rating systems and symbols, even though the symbols themselves can be found anywhere on the front of a food package or on a retail shelf tag. Though not regulated and inconsistent in format, content, and criteria, FOP systems and symbols have the potential to provide useful guidance to consumers as well as maximize effectiveness. As a result, Congress directed the Centers for Disease Control and Prevention (CDC) to undertake a study with the Institute of Medicine (IOM) to examine and provide recommendations regarding FOP nutrition rating systems and symbols. The study was completed in two phases. Phase I focused primarily on the nutrition criteria underlying FOP systems. Phase II builds on the results of Phase I while focusing on aspects related to consumer understanding and behavior related to the development of a standardized FOP system. Front-of-Package Nutrition Rating Systems and Symbols focuses on Phase II of the study. The report addresses the potential benefits of a single, standardized front-label food guidance system regulated by the Food and Drug Administration, assesses which icons are most effective with consumer audiences, and considers the systems/icons that best promote health and how to maximize their use.

Download or read book FDA s Drug Review Process and the Package Label written by Tom Brody and published by Academic Press. This book was released on 2017-12-01 with total page 671 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. - Reveals strategies for winning FDA approval and for drafting the package label - Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases - This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug

Download or read book History of Drug Containers and Their Labels written by George B. Griffenhagen and published by Amer. Inst. History of Pharmacy. This book was released on 1999 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book A Food Labeling Guide written by and published by . This book was released on 1999 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Prescription Drugs written by Sarah F. Jagger and published by . This book was released on 1996 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Standardizing Medication Labels written by Institute of Medicine and published by National Academies Press. This book was released on 2008-05-15 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medications are an important component of health care, but each year their misuse results in over a million adverse drug events that lead to office and emergency room visits as well as hospitalizations and, in some cases, death. As a patient's most tangible source of information about what drug has been prescribed and how that drug is to be taken, the label on a container of prescription medication is a crucial line of defense against such medication safety problems, yet almost half of all patients misunderstand label instructions about how to take their medicines. Standardizing Medication Labels: Confusing Patients Less is the summary of a workshop, held in Washington, D.C. on October 12, 2007, that was organized to examine what is known about how medication container labeling affects patient safety and to discuss approaches to addressing identified problems.

Download or read book Preventing Medication Errors written by Institute of Medicine and published by National Academies Press. This book was released on 2007-01-11 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1996 the Institute of Medicine launched the Quality Chasm Series, a series of reports focused on assessing and improving the nation's quality of health care. Preventing Medication Errors is the newest volume in the series. Responding to the key messages in earlier volumes of the seriesâ€"To Err Is Human (2000), Crossing the Quality Chasm (2001), and Patient Safety (2004)â€"this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. Preventing Medication Errors also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.

Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Download or read book FDA Approved Animal Drug Products written by and published by . This book was released on 1998 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Standards and Labeling Policy Book written by United States. Food Safety and Inspection Service. Standards and Labeling Division and published by . This book was released on 1991 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Prescription Drug Labeling and Price Advertising written by United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Consumer Protection and Finance and published by . This book was released on 1976 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Download or read book Promotion of FDA regulated Medical Products written by Joanne S. Hawana and published by . This book was released on 2018 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: Promotion of FDA-Regulated Medical Products is the update of the 2013 publication, FDA requirements for prescription drug promotion, by John Driscoll.

Download or read book Fair Packaging Labeling Act written by United States. Food and Drug Administration and published by . This book was released on 1978 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Prescription Drugs written by United States Accounting Office (GAO) and published by Createspace Independent Publishing Platform. This book was released on 2018-06-14 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt: Prescription Drugs: Implications of Drug Labeling and Off-Label Use

Download or read book Labeling of Alcoholic Beverages Under the Federal Food Drug and Cosmetic Act written by United States. Food and Drug Administration and published by . This book was released on 1976 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Electronic Drug Labeling written by U.s. Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2017-08-05 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt: " Public health experts note the importance of providing physicians, pharmacists, and consumers with the most current prescription drug information to help inform their respective decisions on which drugs to prescribe, how best to counsel patients, and how to use drugs safely. FDA reviews manufacturer-developed drug labeling, which is generally available in paper form. However, prescription drug labeling is also publicly available in electronic form on government-operated websites. Drug manufacturers have supported eliminating paper labeling, thus relying on electronic drug labeling as a complete substitute for paper labeling. However, others, such as drug labeling manufacturers and patient advocates, disagree, suggesting that it could adversely affect public health. GAO was mandated to examine the benefits and efficiencies of electronic labeling as a partial or complete substitute and its impact on public health. Because drug labeling is already available in electronic form, representing a partial substitute, this report focuses on (1) the advantages and disadvantages of relying on electronic labeling as a complete substitute for paper labeling and (2) the barriers associated with relying on electronic labeling as a complete substitute for paper labeling. GAO interviewed federal officials, including those from FDA, and stakeholders representing physicians, pharmacies, patients, drug manufacturers, and drug labeling"