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.

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

The die-cutting and tooling process is among the most critical areas of label converting and finishing. The sophisticated technology it uses enables the production of quality die-cut and converted labels and their application to multiple surfaces, using a wide variety of substrates, on many different presses. With a better understanding of this often overlooked discipline, you can improve production standards and significantly reduce costly downtime due to pressure-sensitive quality faults. This book explains the complex and vital role die-cutting and tooling plays. Through a series of detailed explanations, photographs, diagrams and charts, the author provides a detailed look at modern tooling technology - how the tools are manufactured, their use and applications, how they should be handled and stored. It includes a section on troubleshooting on the production line and a glossary of terms to ensure any unknown phrases are quickly understood within context. Label converters, industry suppliers and label buyers and all other professionals involved in label converting and finishing will find this book a valuable reference source that helps them run a more profitable business. Chapters include: The label printing and converting process Die-cutting of label webs to shape and size Optimizing the die-cutting process Special tooling for cutting, perforating, hole punching and slitting The nature, use and manufacture of embossing dies and cylinders The hot foiling process and the use and manufacture of foiling dies Cylinders, anvils, support rollers and magnetic cylinders Ancillary equipment for setting, measuring, testing, monitoring and adjusting tooling Inspecting, cleaning, handling, storage and safety considerations A guide to troubleshooting when using label dies and related tooling Glossary of die-cutting and tooling terminology

The growth in private labels has huge implications for managers on both sides.