FORTI Publications - Life Sciences Law: Federal Regulation of Drugs, Biologics,Medical Devices, Foods and Dietary Supplements

The on-line purchase below is available for one pair of the
Life Sciences Law Text
& its companion
Statutory CD only.

All other orders should be placed using the printable form for U.S.mail.

To begin order, please enter Institution name and your Position in the fields below:

Institution
Educator Position or Student Course#

The Buy Now button is valid for
One pair of the
Life Sciences Law Book AND
Statutory CD
The cost of one pair is $125.00*.
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Ordering for
ACADEMIC EDUCATORS, STUDENTS & GOVERNMENT

THIRD EDITION

Life Sciences Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements

Roseann B. Termini, Esq.

THE Food, Drug and Cosmetic Law Textbook

Thoroughly updated for 2007

A comprehensive analysis of food and drug law topics and the federal agencies that regulate this burgeoning industry. A Critical Analysis of the Issues completes each chapter.

Latest All-Inclusive Textbook

This all-inclusive resource imparts the latest information on issues and case studies in Food Safety, Dietary Supplements, Human and Veterinary Drugs, Medical Devices, Radiation Emitting Products, Cosmetics, and Biologics.

Going beyond the role and mission of the United States Food and Drug Administration’s (FDA) and the United States Department of Agriculture (USDA), this text provides a practical format and approach to a complex area of law for those in the regulated professional health community: pharmacy, food, medicine, law, the dietary supplement, nursing and biotechnology.

Combined with the companion Statutory CD it is all any educator, student or professional will need.

Electronic Searchable Statutory CD
3rd Edition
Roseann B. Termini, Esq.

The entire Federal Food, Drug and Cosmetic Act 21 U.S.C. §§ 301 et seq., is included in the Statutory Supplement as well as important sections from related laws. The reader has the added advantage of consulting the separately bound supplement while reading the text, eliminating the need for another source for "FDA law."
Unique to this Supplement is the Title21 Special Statutory Conversion Chart.

Also contains links to related websites.

Training/Teacher's Manual
Roseann B. Termini

This easy-to-follow instruction manual imparts a wealth of information for the instructor. Included are essential teaching strategies, the "top 20" effective teaching tips, detailed chapter-by-chapter listing of key websites, suggested classroom exercises and research projects, and more.

Click here for printable mail order form

TOP ACADEMIC OBJECTIVES

Provides latest on landmark legislation, cases and First Amendment issues
Details federal administrative law topics
Specify FDA and USDA enforcement strategies: recalls, warning letter, criminal convictions, consent decrees
Describe medical device regulation and surveillance
Explore human drug approval processes: OTC; post market risk assessment; adverse events; guidance documents on direct-to-consumer advertising; and duty-to-warn issues;
Detail information on veterinary product misbranding, including animal feed;
Present information on biologics: allergenics, tissue, blood regulation, vaccines, gene therapy;
Explain cosmetic regulation and product classification;
Explore food safety issues, claims, biotechnology, obesity
Clarify dietary supplement regulation including advertising and claims.

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Life Sciences Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements,
Electronic Searchable Statutory CD, Teacher's Manual