A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition PDF Download
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Author: Stephen M. Kanovsky
Publisher:
ISBN: 9781935065876
Category : Drugs
Languages : en
Pages : 672
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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
Get Book
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 : 256
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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: Alex Kreit
Publisher:
ISBN: 9781611637892
Category :
Languages : en
Pages : 1128
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Book Description
Author: George S. Steffen
Publisher: CRC Press
ISBN: 1420091778
Category : Computers
Languages : en
Pages : 322
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Book Description
As drug trafficking and the abuse of illicit drugs continue to inflict untold harm upon our society, it is clear that a global initiative and an intense domestic strategy are vital to address the sophisticated drug trafficking organizations (DTOs) that are prevalent in many regions. Covering a wide array of domestic interdiction topics, Drug Interd
Author: Roseann B. Termini
Publisher:
ISBN: 9780984356171
Category : Biologicals
Languages : en
Pages : 0
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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: James Robert Nielsen
Publisher: Lippincott Williams & Wilkins
ISBN:
Category : Law
Languages : en
Pages : 282
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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: Thomas D McKay
Publisher: Aspatore Books
ISBN: 9780314276278
Category : Law
Languages : en
Pages : 171
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Book Description
Drug Law Enforcement Strategies provides an authoritative, insider's perspective on the intricacies of drug crimes, investigations, and trials. Featuring law enforcement officials from around the country, this book guides the reader through the latest trends in the narcotics arenaincluding new drugs entering the market, the medical marijuana controversy, and the role of technology in investigationswhile analyzing how these issues are impacting procedures. These skilled authors highlight proven methods for embarking on an investigation, creating drug-specific case strategies, working with informants, going undercover, and setting short- and long-term goals for an investigation. Looking at the investigator's role in bringing a drug case to court, they also explain how to supply effective evidence, work successfully with prosecutors, and anticipate questions from defense attorneys. Additionally, these leaders reveal their strategies for collaborating with other agencies, training investigators, and coping with shrinking budgets and limited manpower. The different niches represented and the breadth of perspectives presented enable readers to get inside some of the great legal minds of today, as these experienced officers offer up their thoughts on the keys to success within this ever-evolving field.
Author: Mona Lynch
Publisher: Russell Sage Foundation
ISBN: 1610448618
Category : Social Science
Languages : en
Pages : 206
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Book Description
The convergence of tough-on-crime politics, stiffer sentencing laws, and jurisdictional expansion in the 1970s and 1980s increased the powers of federal prosecutors in unprecedented ways. In Hard Bargains, social psychologist Mona Lynch investigates the increased power of these prosecutors in our age of mass incarceration. Lynch documents how prosecutors use punitive federal drug laws to coerce guilty pleas and obtain long prison sentences for defendants—particularly those who are African American— and exposes deep injustices in the federal courts. As a result of the War on Drugs, the number of drug cases prosecuted each year in federal courts has increased fivefold since 1980. Lynch goes behind the scenes in three federal court districts and finds that federal prosecutors have considerable discretion in adjudicating these cases. Federal drug laws are wielded differently in each district, but with such force to overwhelm defendants’ ability to assert their rights. For drug defendants with prior convictions, the stakes are even higher since prosecutors can file charges that incur lengthy prison sentences—including life in prison without parole. Through extensive field research, Lynch finds that prosecutors frequently use the threat of extremely severe sentences to compel defendants to plead guilty rather than go to trial and risk much harsher punishment. Lynch also shows that the highly discretionary ways in which federal prosecutors work with law enforcement have led to significant racial disparities in federal courts. For instance, most federal charges for crack cocaine offenses are brought against African Americans even though whites are more likely to use crack. In addition, Latinos are increasingly entering the federal system as a result of aggressive immigration crackdowns that also target illicit drugs. Hard Bargains provides an incisive and revealing look at how legal reforms over the last five decades have shifted excessive authority to federal prosecutors, resulting in the erosion of defendants’ rights and extreme sentences for those convicted. Lynch proposes a broad overhaul of the federal criminal justice system to restore the balance of power and retreat from the punitive indulgences of the War on Drugs.
Author: Mark A. Kleiman
Publisher:
ISBN:
Category : Political Science
Languages : en
Pages : 508
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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: Upton Sinclair
Publisher:
ISBN:
Category : Chicago (Ill.)
Languages : en
Pages : 442
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Book Description
