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Abstrak :
ABSTRAK
Industrialisasi dan ekspansi bisnis yang dijalankan dengan sistem pasar bebas di Amerika Serikat pada masa Progresif Era memberikan peluang kepada pebisnis produk makanan untuk melakukan tindak kecurangan. Ketiadaan regulasi dan standarisasi produk makanan membuat produsen makanan di Amerika Serikat leluasa untuk memproduksi dan menjual makanan yang tercemar. Skripsi ini menganalisis peran Kepala Biro Kimia Kementrian Agrikultur, Harvey Washington Wiley, dalam membangun kesadaran masyarakat untuk memperjuangkan undang-undang kemurnian makanan tingkat federal di Amerika Serikat pada kurun waktu 1902-1906. Hasil penelitian ini menunjukkan bahwa Harvey Washington Wiley merupakan agensi dalam perubahan regulasi bisnis produk makanan di Amerika Serikat pada tahun 1906. Dengan mengunakan metode sejarah dan pendekatan teori strukturasi milik Giddens, Penelitian ini akan menyelidiki upaya yang dilakukan oleh Harvey Washington Wiley sebagai agensi perubahan, dalam membentuk kesadaran publik dan merangkul berbagai golongan masyarakat yang terkait, guna melahirkan gerakan sosial yang menuntut keberadaan regulasi bisnis produk makanan pertama di Amerika Serikat.

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ABSTRACT
The industrialization and business expansion that run with free market system in United States during the Progressive Era, gives an opportunity for food manufacturers to commit fraud. The absence of food regulations and standarization gives a chance to food manufacturers in the United States to manufacture and sell adulterated food. This study analyzing the role of Harvey Washington Wiley as Head of Bureau Chemistry Department of Agriculture in building public awareness to fight for federal pure food law in the United States 1902 1906 . The result of this research, indicates that Harvey Washington Wiley is the agency in the pure food movement that fight for food business regulations in the United States. Using historical methods and the giddens 39 theory of structuration, this research investigate the efforts that made by Harvey Washington Wiley as agency, in forming public awareness and embrace various groups to join the pure food movement to deliver pressure to the congress to ratify the first Pure Food and Drug Act in United States.

Abstrak :
This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators.

Abstrak :
A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval. The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are: The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products Approaches to clinical trial protocol design and execution Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products Key sponsor/FDA meetings and negotiations essential for approval and commercialization Case studies involving such actual combination products as Mylotarg, Herceptin, and HercepTest help you better understand how to implement the author's practical guidelines. References at the end of each chapter enable you to find more information on any stage of the development, manufacturing and approval processes.

Abstrak :
This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.