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Author: Stephen M. Kanovsky Publisher: ISBN: 9781935065876 Category : Drugs Languages : en Pages : 672
Book Description
FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.
Author: Stephen M. Kanovsky Publisher: ISBN: 9781935065876 Category : Drugs Languages : en Pages : 672
Book Description
FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.
Author: Mark A.R. Kleiman Publisher: Oxford University Press ISBN: 0199831386 Category : Political Science Languages : en Pages : 258
Book Description
While there have always been norms and customs around the use of drugs, explicit public policies--regulations, taxes, and prohibitions--designed to control drug abuse are a more recent phenomenon. Those policies sometimes have terrible side-effects: most prominently the development of criminal enterprises dealing in forbidden (or untaxed) drugs and the use of the profits of drug-dealing to finance insurgency and terrorism. Neither a drug-free world nor a world of free drugs seems to be on offer, leaving citizens and officials to face the age-old problem: What are we going to do about drugs? In Drugs and Drug Policy, three noted authorities survey the subject with exceptional clarity, in this addition to the acclaimed series, What Everyone Needs to Know®. They begin, by defining "drugs," examining how they work in the brain, discussing the nature of addiction, and exploring the damage they do to users. The book moves on to policy, answering questions about legalization, the role of criminal prohibitions, and the relative legal tolerance for alcohol and tobacco. The authors then dissect the illicit trade, from street dealers to the flow of money to the effect of catching kingpins, and show the precise nature of the relationship between drugs and crime. They examine treatment, both its effectiveness and the role of public policy, and discuss the beneficial effects of some abusable substances. Finally they move outward to look at the role of drugs in our foreign policy, their relationship to terrorism, and the ugly politics that surround the issue. Crisp, clear, and comprehensive, this is a handy and up-to-date overview of one of the most pressing topics in today's world. What Everyone Needs to Know® is a registered trademark of Oxford University Press.
Author: Committee on Federal Regulation of Methadone Treatment Publisher: National Academies Press ISBN: 0309598621 Category : Medical Languages : en Pages : 251
Book Description
For nearly three decades, methadone hydrochloride has been the primary means of treating opiate addiction. Today, about 115,000 people receive such treatment, and thousands more have benefited from it in the past. Even though methadone's effectiveness has been well established, its use remains controversial, a fact reflected by the extensive regulation of its manufacturing, labeling, distribution, and use. The Food and Drug Administration regulates the safety and effectiveness of methadone, as it does for all drugs, and the Drug Enforcement Administration regulates it as a controlled substance. However, methadone is also subjected to a unique additional tier of regulation that prescribes how and under what circumstances it may be used to treat opiate addiction. Federal Regulation of Methadone Treatment examines current Department of Health and Human Services standards for narcotic addiction treatment and the regulation of methadone treatment programs pursuant to those standards. The book includes an evaluation of the effect of federal regulations on the provision of methadone treatment services and an exploration of options for modifying the regulations to allow optimal clinical practice. The volume also includes an assessment of alternatives to the existing regulations.
Author: James Robert Nielsen Publisher: Lippincott Williams & Wilkins ISBN: Category : Law Languages : en Pages : 282
Book Description
"[A}fter reading this handbook a student or practitioner should be able to examine any drug distribution system or professional practice and determine if the system or practice is lawful within the terms of the federal drug law."--From preface.
Author: Roseann B. Termini Publisher: ISBN: 9780984356171 Category : Biologicals Languages : en Pages : 0
Book Description
This food and drug law comprehensive book is organized for ease of reading in order to comprehend a complex area of federal regulatory law. There is a separate volume for each subject based on regulation under the United States Federal Food, Drug and Cosmetic Act (FDCA) and related laws all contained in this bound book. Food and Drug Law is organized into subject specific titled volumes with a concise introduction to provide a particular focus for the reader. Praise for Food and Drug LawFood and Drug law has many audiences besides lawyers - health care personnel, doctors, nurses, regulatory, and CEO's to name a few and the author writes in "Plain Language" for reader appeal. - Thomas Mc Grath, M.D., J.D. This is an excellent up-to-date resource. It is used in my graduate school courses as well as in industry. Students keep it as a "desk-top-reference." - Thomas E. Colonna PhD/JD, Director Regulatory Science Program The author details the complexities into subject specific areas. She provides critical information using a practical approach so rare today! - Albert Wertheimer, PhD. Prof. Nova Southeastern University
Author: Mark A. Kleiman Publisher: ISBN: Category : Political Science Languages : en Pages : 508
Book Description
Drug-taking and drug control are alike; both are often done to excess. Against Excess shows how we can limit the damage done by drugs and the damage done by drug policies.
Author: William N. Brownsberger Publisher: Harvard University Press ISBN: 0674038622 Category : Medical Languages : en Pages : 284
Book Description
This book is the culmination of five years of debate among distinguished scholars in law, public policy, medicine, and biopsychology, about the most difficult questions in drug policy and the study of addictions. Do drug addicts have an illness, or is the addiction under their control? Should they be treated as patients or as criminals? Challenging the conventional wisdom, the authors show that these standard dichotomies are false.
Author: Mark A. R. Kleiman Publisher: SAGE Publications ISBN: 1506338240 Category : Political Science Languages : en Pages : 1009
Book Description
Spanning two volumes of approximately 450 entries in an A-to-Z format, this encyclopedia explores the controversial drug war through the lens of varied disciplines. A full spectrum of articles explains topics from Colombian cartels and Mexican kingpins to television reportage; from "just say no" advertising to heroin production; and from narco-terrorism to more than $500 billion in U.S. government expenditures. Key Themes- Cases- Conferences and Conventions- Countries (Affecting U.S. Drug Policy)- Drug Trade and Trafficking- Laws and Policies- Organizations and Agencies- People-Presidential Administrations- Treatment and Addiction- Types of Drugs
Author: Stephen M. Kanovsky
Author: Stephen M. Kanovsky
Author: Mark A.R. Kleiman
Author: Alex Kreit
Author: Committee on Federal Regulation of Methadone Treatment
Author: James Robert Nielsen
Author: Roseann B. Termini
Author: Mark A. Kleiman
Author: Upton Sinclair
Author: William N. Brownsberger
Author: Mark A. R. Kleiman