FEDERAL REGULATION DRUGS, BIOLOGICS, DEVICES, FOODS, DIETARY SUPPLEMENTS, PERSONAL CARE, VETERINARY, TOBACCO PRODUCTS: FOOD AND DRUG LAW

by Roseann B. Termini, Esq.

Overview

This comprehensive food and drug law resource, "Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products Regulation," is organized for ease of reading in order to comprehend a complex area of law. This easy to navigate treatise is well-ordered into separate Books with a concise introduction to provide a particular focus for the reader. This reference contains a distinct Book for each subject based on regulation under the United States Federal Food, Drug and Cosmetic Act (FDCA) and related law. The Titles of each Book contained in this All Inclusive Book are as follows:
Book I: The "Why" of the U. S. Food and Drug Administration, Landmark Legislation, Court Decisions
Book II: Food and Drug Law Administrative Primer
Book III: The Food and Drug Administration—Criminal and Civil Enforcement Strategies
Book IV: Medical Device and Radiation Emitting Products Regulation
Book V: Human Drug Regulation—Approvals, Promotion, Marketing, Warnings, Accountability, and Post-market Surveillance
Book VI: Biotechnology and Biologics Regulation—Biosimilars, Allergenics, Tissue, Blood, Vaccines and Gene Therapy Products
Book VII: Veterinary Products Regulation
Book VIII: Personal Care Products Regulation—Safety, Product Classification and Enforcement
Book IX: Food Regulation—Food Safety, Recalls, Claims, Additives, Allergens and Biotechnology
Book X: Dietary Supplements, Herbs and Botanicals Regulation
Book XI: Tobacco Products Regulation
This comprehensive food and drug law resource, "Food and Drug Law: Federal Regulation of Drugs, Biolog-ics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products Regulation," is organized for ease of reading in order to comprehend a complex area of law. This easy to navigate treatise is well-ordered into separate Books with a concise introduction to provide a particular focus for the reader. This reference contains a distinct Book for each subject based on regulation under the United States Federal Food, Drug and Cosmetic Act (FDCA) and related law. This entire work serves as an inclusive resource for the:
Regulated industry such as legal counsel and regulatory affairs;
Legal practitioners whose practice involves food, medical devices, drugs, biologics, personal care,
veterinary, dietary supplements and tobacco products regulatory law;
Attorneys in related disciplines who find themselves in the crosshairs of the FDCA;
Academic community including professors and students searching for a clear resource; and
Government personnel—federal, state and local involved in these topics.
Book XII: Professionalism, Politics, Foreign Corrupt Practices, Product Classification,
Globalization and the Future
This entire work serves as an inclusive resource for the:
Regulated industry such as legal counsel and regulatory affairs;
Legal practitioners whose practice involves food, medical devices, drugs, biologics, personal care,
veterinary, dietary supplements and tobacco products regulatory law;
Attorneys in related disciplines who find themselves in the crosshairs of the FDCA;
Academic community including professors and students searching for a clear resource; and
Government personnel—federal, state and local involved in these topics.

Product Details

BN ID:	2940161025925
Publisher:	Forti Publications
Publication date:	01/10/2022
Sold by:	Barnes & Noble
Format:	eBook
File size:	2 MB

About the Author

Roseann B. Termini, B.S., Ed. M., J.D. has over thirty years of extensive experience in food and drug law. These 12 Books, all contained in this new tenth edition, emanate from her comprehensive food and drug regulatory law books. Ms. Termini has frequently presented food and drug law topics as a featured international and national speaker. Further, she has published a broad array of specialized food and drug law issues such as corporate accounta-bility, criminal liability, enforcement, health claims, dietary supplements, safety, duty to warn, preemption, regula-tion, promotion, tobacco, stem cells, risk assessment, right-to-try and globalization. She was the inaugural recipient of the Plain English Award by the Pennsylvania Bar Association. Her expertise includes an appellate clerkship, sole corporate counsel, regulatory attorney and senior deputy attorney general at the Pennsylvania Office of Attorney General (OAG). While at the OAG, she prosecuted cases at the trial and appellate levels and was in charge of im-plementation procedures for the Pennsylvania Plain Language Act. Ms. Termini designed and developed the inaugu-ral online food and drug law courses at Delaware Law School of Widener University, Johns Hopkins University, the University of Georgia, Drexel University and pharmaceutical promotion courses at St. Joseph’s University’s Execu-tive Program. Ms. Termini has also taught food and drug law courses at Temple University’s Quality and Regulato-ry Affairs Graduate Program and Dickinson School of Law. She was appointed to Immaculata University Presi-dent’s Council. Ms. Termini has been active in professional associations for numerous years, including her service as Academic Chair of a Food and Drug Law Committee and Vice Chancellor of the Justinian Society. She is Co-Chair of the Pennsylvania Bar Association Health Law and Vice-Chair, Disability Rights Committees, Board member of the St. Thomas More Law Society and is involved in the Central Atlantic States Association of Food and Drug Law Officials. In 2018, Ms. Termini was admitted to the Bar of the United States Supreme Court.