The Regulation of Animal Drugs by the Food and Drug Administration

The Regulation of Animal Drugs by the Food and Drug Administration PDF Author: United States. Congress. House. Committee on Government Operations. Intergovernmental Relations and Human Resources Subcommittee
Publisher:
ISBN:
Category : Medicated feeds
Languages : en
Pages : 940

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The Regulation of Animal Drugs by the Food and Drug Administration

The Regulation of Animal Drugs by the Food and Drug Administration PDF Author: United States. Congress. House. Committee on Government Operations. Intergovernmental Relations and Human Resources Subcommittee
Publisher:
ISBN:
Category : Medicated feeds
Languages : en
Pages : 940

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Book Description


FDA Approved Animal Drug Products

FDA Approved Animal Drug Products PDF Author:
Publisher:
ISBN:
Category : Veterinary drugs
Languages : en
Pages : 144

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The Use of Drugs in Food Animals

The Use of Drugs in Food Animals PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309175771
Category : Medical
Languages : en
Pages : 276

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Book Description
The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.

Human Food Safety and the Regulation of Animal Drugs

Human Food Safety and the Regulation of Animal Drugs PDF Author: United States. Congress. House. Committee on Government Operations
Publisher:
ISBN:
Category : Feed additive residues
Languages : en
Pages : 126

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Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration

Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration PDF Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Cosmetics
Languages : en
Pages : 84

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Generic Animal Drug and Patent Term Restoration Act

Generic Animal Drug and Patent Term Restoration Act PDF Author: United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of Justice
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 196

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New Animal Drugs for Use in Animal Feed - Approval of New Animal Drug Applications - Withdrawal of Approval of New Animal Drug Applications (Us Food and Drug Administration Regulation) (Fda) (2018 Edition)

New Animal Drugs for Use in Animal Feed - Approval of New Animal Drug Applications - Withdrawal of Approval of New Animal Drug Applications (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) PDF Author: The Law The Law Library
Publisher: Createspace Independent Publishing Platform
ISBN: 9781727529357
Category :
Languages : en
Pages : 52

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Book Description
New Animal Drugs for Use in Animal Feed - Approval of New Animal Drug Applications - Withdrawal of Approval of New Animal Drug Applications (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the New Animal Drugs for Use in Animal Feed - Approval of New Animal Drug Applications - Withdrawal of Approval of New Animal Drug Applications (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 71 supplemental new animal drug applications (NADAs) and 35 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) use to use by veterinary feed directive (VFD) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and ANADAs that were affected by this initiative. The animal drug regulations are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations. This book contains: - The complete text of the New Animal Drugs for Use in Animal Feed - Approval of New Animal Drug Applications - Withdrawal of Approval of New Animal Drug Applications (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section

Animal Biotechnology

Animal Biotechnology PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309084393
Category : Technology & Engineering
Languages : en
Pages : 201

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Book Description
Genetic-based animal biotechnology has produced new food and pharmaceutical products and promises many more advances to benefit humankind. These exciting prospects are accompanied by considerable unease, however, about matters such as safety and ethics. This book identifies science-based and policy-related concerns about animal biotechnologyâ€"key issues that must be resolved before the new breakthroughs can reach their potential. The book includes a short history of the field and provides understandable definitions of terms like cloning. Looking at technologies on the near horizon, the authors discuss what we know and what we fear about their effectsâ€"the inadvertent release of dangerous microorganisms, the safety of products derived from biotechnology, the impact of genetically engineered animals on their environment. In addition to these concerns, the book explores animal welfare concerns, and our societal and institutional capacity to manage and regulate the technology and its products. This accessible volume will be important to everyone interested in the implications of the use of animal biotechnology.

New Animal Drugs - Change of Sponsor (Us Food and Drug Administration Regulation) (Fda) (2018 Edition)

New Animal Drugs - Change of Sponsor (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) PDF Author: The Law The Law Library
Publisher: Createspace Independent Publishing Platform
ISBN: 9781727529197
Category :
Languages : en
Pages : 46

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Book Description
New Animal Drugs - Change of Sponsor (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the New Animal Drugs - Change of Sponsor (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 54 approved new animal drug applications (NADAs) and 1 approved abbreviated new animal drug application (ANADA) for topical, intramammary, and certain other dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc. This book contains: - The complete text of the New Animal Drugs - Change of Sponsor (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section

An Overview of FDA Regulated Products

An Overview of FDA Regulated Products PDF Author: Eunjoo Pacifici
Publisher: Academic Press
ISBN: 0128111569
Category : Medical
Languages : en
Pages : 292

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Book Description
Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations