FDA's Regulation of the Marketing of Unapproved New Drugs

FDA's Regulation of the Marketing of Unapproved New Drugs PDF Author: United States. Congress. House. Committee on Government Operations. Intergovernmental Relations and Human Resources Subcommittee
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 526

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FDA's Regulation of the Marketing of Unapproved New Drugs

FDA's Regulation of the Marketing of Unapproved New Drugs PDF Author: United States. Congress. House. Committee on Government Operations. Intergovernmental Relations and Human Resources Subcommittee
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 526

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Book Description


Promoting Safety of Medicines for Children

Promoting Safety of Medicines for Children PDF Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241563435
Category : Medical
Languages : en
Pages : 65

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Book Description
Monitoring the safety of medicine use in children is of paramount importance since during the clinical development of medicines only limited data on this aspect are generated through clinical trials. Use of medicines outside the specifications described in the license (e.g. in terms of formulation indications contraindications or age) constitutes off-label and off-license use and these are a major area of concern. These guidelines are intended to improve awareness of medicine safety issues among everyone who has an interest in the safety of medicines in children and to provide guidance on effective systems for monitoring medicine safety in pediatric populations. This book will be of interest to all health care professionals medicine regulatory authorities pharmacovigilance centres academia the pharmaceutical industry and policy-makers. Systems for monitoring medicine safety are described in Annex 1. Pharmacovigilance methods and some examples of recent information on adverse reactions to marketed medicines are discussed in Annex 2.

Pastoralism and Socio-technological Transformations in Northern Benin

Pastoralism and Socio-technological Transformations in Northern Benin PDF Author: Georges Djohy
Publisher: Göttingen University Press
ISBN: 3863953460
Category : Agriculture
Languages : en
Pages : 368

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Book Description
Pastoralists throughout Africa face increasing pressures. In Benin, governmental development policies and programmes in crop farming are changing power relations between herders and farmers to favour the latter. How are the Fulani pastoralists responding to these threats to their existence? Georges Djohy explores the dynamics in local use of natural resources and in inter-ethnic relations resulting from development interventions. He combines the approaches of science and technology studies – looking at the co-construction of society and technology – and political ecology – looking at the power relations shaping the dynamics of economic, environmental and social change – so as to throw light on the forces of marginalisation, adaptation and innovation at work in northern Benin. Having worked there for many years, Djohy has been able to uncover gradual processes of socio-technological change that are happening “behind the scenes” of agricultural development involving mechanisation, herbicide use, tree planting, land registration and natural resource conservation. He reveals how farmers are using these interventions as “weapons” in order to gain more rights over larger areas of land, in other words, to support indigenous land grabbing from herders who had been using the land since decades for grazing. He documents how the Fulani are innovating to ensure their survival, e.g. by using new technologies for transport and communication, developing new strategies of livestock feeding and herd movement, and developing complementary sources of household income. The Fulani are organising themselves from local to national level to provide technological and socio-cultural services, manage conflicts and gain a stronger political voice, e.g. to be able to achieve demarcation of corridors for moving livestock through cultivated areas. They even use non-functioning mini-dairies – another example of development intervention – to demonstrate their modernity and to open up other opportunities to transform their pastoral systems. This book provides insights into normally hidden technical and social dynamics that are unexpected outcomes of development interventions.

100 Great War Movies

100 Great War Movies PDF Author: Robert J. Niemi
Publisher:
ISBN:
Category : History
Languages : en
Pages : 0

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Book Description
This book serves as a fascinating guide to 100 war films from 1930 to the present. Readers interested in war movies will learn surprising anecdotes about these films and will have all their questions about the films' historical accuracy answered. This cinematic guide to war movies spans 800 years in its analysis of films from those set in the 13th century Scottish Wars of Independence (Braveheart) to those taking place during the 21st-century war in Afghanistan (Lone Survivor). World War II has produced the largest number of war movies and continues to spawn recently released films such as Dunkirk. This book explores those, but also examines films set during such conflicts as the Napoleonic Wars, the American Civil War, World War I, the Vietnam War, and the wars in Afghanistan and Iraq. The book is organized alphabetically by film title, making it easy to navigate. Each entry is divided into five sections: Background (a brief discussion of the film's genesis and financing); Production (information about how, where, and when the film was shot); Synopsis (a detailed plot summary); Reception (how the film did in terms of box office, awards, and reviews) and "Reel History vs. Real History" (a brief analysis of the film's historical accuracy). This book is ideal for readers looking to get a vivid behind-the-scenes look at the greatest war movies ever made.

The Inconvenient Indigenous

The Inconvenient Indigenous PDF Author: Sidsel Saugestad
Publisher: Nordic Africa Institute
ISBN: 9789171064752
Category : Business & Economics
Languages : en
Pages : 274

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Book Description
Saugestad examines the relationship between the government of Botswana and its indigenous minority, variously known as Bushmen, San, Basarwa, or more recently Noakwe.

Pediatric Drug Formulations

Pediatric Drug Formulations PDF Author: Milap Nahata
Publisher:
ISBN: 9780929375144
Category : Medical
Languages : en
Pages :

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Herbs of Choice

Herbs of Choice PDF Author: Varro E. Tyler
Publisher: Haworth Press
ISBN:
Category : Gardening
Languages : en
Pages : 240

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Book Description
Provides information about the therapeutic use of herbs and their common preparations.

Functional Foods

Functional Foods PDF Author: I. Goldberg
Publisher: Springer Science & Business Media
ISBN: 1461520738
Category : Technology & Engineering
Languages : en
Pages : 579

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Book Description
"Accuse not Nature! She has done her part; Do Thou but Thine!" Milton, Paradise Lost 1667 The concept that nature imparted to foods a health-giving and curative function is not new. Herbal teas and remedies have been used for centuries and continue in use in many parts of the world today. In modern society, we have turned to drugs to treat, miti gate, or prevent diseases. However, since the discovery of nutrients and our increasing analytical capabilities at the molecular level, we are beginning to become more knowledgeable of the biochemical structure-function relationship of the myriad of chemicals that occur naturally in foods and their effect on the human body. The holistic approach to medicine and diet that began in the 1970s has now seen a renewal as we realize that certain foods, because of the presence of specific biochemicals, can have a positive impact on an individual's health, physical well-being, and mental state. In fact, because of the negative image of drugs, and the grey area of s- xi Foreword xii plements, the use of foods that are "functional" is becoming a growth area for the food industry. In Japan this concept has led to one of the largest growing markets, where they have defined "functional foods" as regular foods derived only from naturally occurring in gredients. The Japanese further require that the functional foods be consumed as part of the diet and not in supplement form (i. e.

Bushmen and Diamonds

Bushmen and Diamonds PDF Author: Kenneth Good
Publisher: Nordic Africa Institute
ISBN: 9789171065209
Category : Business & Economics
Languages : en
Pages : 44

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Book Description
Botswana's democracy is often considered to be a comparatively advanced and positive example of an African state in terms of political culture and the notion of 'good governance'. This paper challenges the assumption that the country's current political and socio-economic system is, in fact, exemplary. It highlights some of the limitations by focusing on the particular situation of the Bushmen/San as a marginalized minority denied citizens' rights and losing out against the material interests accompanying the exploration and exploitation of diamonds, the most lucrative natural resource contributing to Botswana's 'success story'.The author has on previous occasions presented and published related analyses within the research network on 'Liberation and Democracy in Southern Africa' (LiDeSA), which is currently coordinated through the Nordic Africa Institute. This publication is another result of the collaboration within this project.

Health Care Fraud and Abuse

Health Care Fraud and Abuse PDF Author: Aspen Health Law Center
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 156

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Book Description
Stepped-up efforts to ferret out health care fraud have put every provider on the alert. The HHS, DOJ, state Medicaid Fraud Control Units, even the FBI is on the case -- and providers are in the hot seat! in this timely volume, you'll learn about the types of provider activities that fall under federal fraud and abuse prohibitions as defined in the Medicaid statute and Stark legislation. And you'll discover what goes into an effective corporate compliance program. With a growing number of restrictions, it's critical to know how you can and cannot conduct business and structure your relationships -- and what the consequences will be if you don't comply.