A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition
Author: Stephen M. Kanovsky
Publisher:
Total Pages: 672
Release: 2020-09
Genre: Drugs
ISBN: 9781935065876

Download A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition Book in PDF, Epub and Kindle

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.

Food and Drug Regulation

Food and Drug Regulation
Author: ADAM I. MUCHMORE
Publisher:
Total Pages: 734
Release: 2021-03-14
Genre:
ISBN: 9781531004453

Download Food and Drug Regulation Book in PDF, Epub and Kindle

The U.S. Food and Drug Law

The U.S. Food and Drug Law
Author: Wallace F. Janssen
Publisher:
Total Pages: 12
Release: 1979
Genre: Drugs
ISBN:

Download The U.S. Food and Drug Law Book in PDF, Epub and Kindle

The Jungle

The Jungle
Author: Upton Sinclair
Publisher:
Total Pages: 442
Release: 1920
Genre: Chicago (Ill.)
ISBN:

Download The Jungle Book in PDF, Epub and Kindle

A Practical Guide to Fda's Food and Drug Law and Regulation, Sixth Edition

A Practical Guide to Fda's Food and Drug Law and Regulation, Sixth Edition
Author: Kenneth R. Piña
Publisher: Food and Drug Law Institute
Total Pages: 618
Release: 2017-08-21
Genre: Law
ISBN: 9781935065845

Download A Practical Guide to Fda's Food and Drug Law and Regulation, Sixth Edition Book in PDF, Epub and Kindle

A Practical Guide to FDA's Food and Drug Law and Regulation provides an introduction to the laws and regulations governing development, marketing, and sale of food, medical products, tobacco, and cosmetics. Structured to serve as a reference and as a teaching tool, each chapter builds sequentially from the last, while providing an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. Written in real-world language, the book offers practical legal/regulatory fundamentals for use by a wide range of people interested in the FDA legal and regulatory scheme. This book is a standard text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including a U.S. Supreme Court opinion). This Sixth Edition incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances. It also incorporates important changes that have resulted from recent court opinions and administrative enforcement actions.

Enhancing Food Safety

Enhancing Food Safety
Author: National Research Council
Publisher: National Academies Press
Total Pages: 589
Release: 2010-11-04
Genre: Medical
ISBN: 0309163587

Download Enhancing Food Safety Book in PDF, Epub and Kindle

Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.

The U.S. food and drug law

The U.S. food and drug law
Author: Wallace F. Janssen
Publisher:
Total Pages: 8
Release: 1979*
Genre: Drugs
ISBN:

Download The U.S. food and drug law Book in PDF, Epub and Kindle

Pain Management and the Opioid Epidemic

Pain Management and the Opioid Epidemic
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 483
Release: 2017-09-28
Genre: Medical
ISBN: 0309459575

Download Pain Management and the Opioid Epidemic Book in PDF, Epub and Kindle

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Federal Regulation of Methadone Treatment

Federal Regulation of Methadone Treatment
Author: Committee on Federal Regulation of Methadone Treatment
Publisher: National Academies Press
Total Pages: 251
Release: 1995-02-01
Genre: Medical
ISBN: 0309598621

Download Federal Regulation of Methadone Treatment Book in PDF, Epub and Kindle

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.