Compilation of food and drug laws (The Food and Drug Law Institute series)

United States

Food and Drug Law Institute

Dietary Supplement Health and Education Act: A legislative history and analysis

Education & Teaching

Bass, I. Scott

Schools & Teaching

An analytical legislative history of FDAMA

From FDLI:  Bringing Your Medical Device to Market guides medical device manufacturers through the complex process of bringing a new product to market. This collaborative publication, edited by John B. Reiss, Ph.D., J.D., Partner and Co-Chair of the Health Law Practice Group, and written by several Saul Ewing attorneys, was published by the Washington, D.C.-based Food and Drug Law Institute (FDLI).Bringing Your Medical Device to Market offers practical advice and step-by-step development tips for manufacturers, attorneys, healthcare professionals, and others. With participation by attorneys from Saul Ewing's Business Department, Health Law Practice Group, Insurance Practice Group, Intellectual Property Practice Group, Labor, Employment and Employee Benefits Practice Group and Litigation Department, the book covers all aspects of the device development cycle, including necessary legal forms, business plan production, receiving FDA approval, obtaining payment for a device, product liability, and marketing the device successfully.

Bringing Your Medical Device to Market

A Practical Guide to Food and Drug Law and Regulation

Medical Books

Pina, Kenneth R., Ed.

Administration & Medicine Economics

Food and Drug Law and RegulationSecond EditionEdited By David G. Adams, Richard M. Cooper, Martin J. Hahn, Jonathan S. Kahan

Food and Drug Law and Regulation

Richard Cooper

David, Adams

Martin Hahn

Janathan Kahn

Why spend countless hours trying to piece together recent amendments to the Federal Food, Drug, and Cosmetic Act (FDCA)? We've done the work of integrating the 2013 changes for you in the latest edition of the Statutory Supplement. The Drug Quality and Security Act amends the FDCA in some very important ways, including: exempting some compounded drugs from certain requirements; establishing annual registration and reporting requirements for outsourcing facilities; establishing track and trace requirements; and requiring the Secretary of Health and Human Services to take additional steps to safeguard health. The 2013 edition of the Statutory Supplement uses an easy-to-follow format highlighting additions and deletions to the statute. This edition includes a complimentary CD with the entire volume in electronic format for greater accessibility.

FDLI's FDCA Statutory Supplement, 2013

Joy J. Liu

Reference

The 2015 edition of FDLI's signature reference work, Food and Drug Law and Regulation is the only comprehensive resource covering the field of food and drug law. For practicing attorneys, regulatory and compliance professionals, and others who need to understand the complex regulatory framework created by FDA and related agencies, including court decisions, legislation, enforcement actions, and international issues.

Food and Drug Law and Regulation, Third Edition

David G. Adams

Richard M. Cooper

Martin J. Hahn

Jonathan S. Kahan

Administrative Law

Off-Label Communications: A Guide to Sales & Marketing Compliance, Fourth Edition

FDLI

Multiple-Authors

Business & Money

Bringing Your Pharmaceutical to Market is designed to provide an overview of the key business, regulatory, and legal issues likely to be encountered throughout the process of commercializing a pharmaceutical drug in the United States. The pharmaceutical industry is unquestionably one of the most heavily regulated and scrutinized in the business world. For anyone interested in understanding the critical milestones and challenges along the path to successfully bringing a life-changing or even life-saving pharmaceutical drug to patients and healthcare professionals, this text will prove essential.

Bringing Your Pharmaceutical Drug to Market

Law Practice

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Books by Food and Drug Law Institute