Roseann B. Termini

Widener University Delaware Law School

4601 Concord Pike

Wilmington, DE 19803-0406

United States

SCHOLARLY PAPERS

39

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Scholarly Papers (39)

1.

Copyright and Trademark Issues in the Pharmaceutical Industry: Generic Compliance or Brand Drug Imitating: 'Copycat or Compliance'

Pennsylvania Bar Association Quarterly, January 2013
Number of pages: 13 Posted: 06 Feb 2013
Roseann B. Termini and Amy Miele
Widener University Delaware Law School and Widener University
Downloads 1,120 (21,691)

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copyright, trademark, pharmaceutical industry, intellectual property, generic drugs

2.

American Beauty: An Analytical View of the Past and Current Effectiveness of Cosmetic Safety Regulations and Future Direction

Food and Drug Law Journal, Vol. 63, No. 1, 2008
Number of pages: 19 Posted: 12 Feb 2009
Roseann B. Termini and Leah B. Tressler
Widener University Delaware Law School and Widener University Delaware Law School
Downloads 574 (54,332)

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cosmetics, regulation, food and drug administration, fda, safety, consumer protection

3.

Whatever Happened to Old Mac Donald’s Farm…Concentrated Animal Feeding Operation, Factory Farming and the Safety of the Nation’s Food Supply

Journal of Food Law and Policy, Vol. 5, No. 1, 2009
Number of pages: 23 Posted: 09 Jan 2010 Last Revised: 29 Sep 2010
Julie A. Follmer and Roseann B. Termini
Select Medical Corporation and Widener University Delaware Law School
Downloads 507 (63,506)

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food safety, CAFO, concentrated animal feeding operation, factory farming, food law, livestock

4.

Food Advertising and Childhood Obesity: A Call to Action for Proactive Solutions

Minnesota Journal of Law, Science & Technology, Vol. 12, No. 2, pp. 619-651, 2011
Number of pages: 32 Posted: 02 Aug 2011
Roseann B. Termini, Thomas A. Roberto and Shelby G. Hostetter
Widener University Delaware Law School, Widener University Delaware Law School and Widener University Delaware Law School
Downloads 414 (81,221)

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obesity, children, advertising, food and drug law

5.

A Practical Guide to Navigating the Medical Device Industry: Advice from Experts in Industry, Law, Intellectual Property and Academia

The Food and Drug Law Institute Monograph Series, Vol. 2, No. 4, 2011
Number of pages: 95 Posted: 03 Jun 2011
Harvard University - T.H. Chan School of Public Health, Holland & Knight LLP, The Foundry, LLC, Widener University Delaware Law School and affiliation not provided to SSRN
Downloads 214 (163,807)

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medical devices, regulation, healthare law, intellectual property, healthcare reform, patents

6.

The Family Smoking Prevention and Tobacco Control Act: A ‘Look Back’ to Understand the Future

Regulatory Focus, June 2011
Number of pages: 3 Posted: 01 Aug 2011
Roseann B. Termini
Widener University Delaware Law School
Downloads 134 (245,397)

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smoking, health law, tobacco products, Food and Drug Administration, FDA

7.

A Compliance Guide to Pennsylvania's 'Plain English' Consumer Contract Law

Pennsylvania Bar Association Quarterly, Vol. 66, No. 2, p. 74, 1995
Number of pages: 5 Posted: 26 May 2012
Roseann B. Termini
Widener University Delaware Law School
Downloads 129 (252,638)

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legal writing, contracts, Pennsylvania, plain language, plain English, consumer contracts

8.

Sex, Politics, and Lessons Learned from Plan B: A Review of the FDA’s Actions and Future Direction

Oklahoma City University Law Review, Vol. 36, 2011
Number of pages: 23 Posted: 25 Jan 2012
Roseann B. Termini and Miranda Lee
Widener University Delaware Law School and Widener University - Delaware Law School
Downloads 113 (278,372)

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plan b, birth control, FDA, Food and Drug Administration, emergency contraceptives

9.

The Role of the United States Federal Food and Drug Administration: Regulator, Watchdog, Facilitator or All of These?

Food and Drug Policy Forum, Vol. 3, No. 11, 2013
Number of pages: 25 Posted: 26 Jul 2013
Roseann B. Termini and Anthony diDonato
Widener University Delaware Law School and Widener University Delaware Law School
Downloads 106 (291,195)

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food and drug law, FDA, Food and Drug Administration, administrative law, public health, pharmaceutical industry

10.

The Role and Mission of the United States Food and Drug Administration: Regulator, Watchdog, Facilitator, or 'All of the Above'

Biotechnology & Pharmaceutical Law Review, v. 7, p. 901, 2014, Widener Law School Legal Studies Research Paper No. 14-27
Number of pages: 34 Posted: 12 Jul 2014 Last Revised: 07 May 2015
Roseann B. Termini and Anthony diDonato
Widener University Delaware Law School and Widener University Delaware Law School
Downloads 96 (310,858)

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FDA, Food and Drug Administration, pharaceutical companies, food and drug law, administrative agencies, regulation

11.

The Family Smoking Prevention and Tobacco Control Act and Public Health

Pennsylvania Bar Association Quarterly, p. 147, October 2010
Number of pages: 16 Posted: 18 Dec 2010
Roseann B. Termini
Widener University Delaware Law School
Downloads 95 (312,920)

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Smoking, Tobacco, FDA, Food and Drug Administration, Public Health, Health Law

12.

The Pharmacist Duty to Warn Revisited: The Changing Role of Pharmacy in Health Care and the Resultant Impact on the Obligation of a Pharmacist to Warn

Ohio North University Law Review, Vol. 24, No. 3, 1998
Number of pages: 16 Posted: 07 Jun 2012
Roseann B. Termini
Widener University Delaware Law School
Downloads 88 (328,578)

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pharmacists, duty to warn, liability, patients, learned intermediary doctrine, negligence, torts, prescription drugs

13.

How to Inform the American Consumer of Healthy Food Choices - Are 'Smart Food Labels' The Proper Tool to Achieve this Goal?

Food and Drug Law Institute Update, No. 4, p. 18, July/August 2010
Number of pages: 5 Posted: 08 Sep 2010
Roseann B. Termini and Nicole Stanzione
Widener University Delaware Law School and Widener University Delaware Law School
Downloads 81 (345,436)

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Food, Labeling, FDA, Food and Drug Administration, Obesity, Nutrition

14.

The Prevention of Misbranded Food Labeling: The Nutrition Labeling and Education Act of 1990 and Alternative Enforcement Mechanisms

Ohio North University Law Review, Vol. 18, No. 1, p. 77, 1991
Number of pages: 32 Posted: 26 May 2012
Roseann B. Termini
Widener University Delaware Law School
Downloads 79 (350,518)

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food labeling, misbranding, deceptive labeling, Food and Drug Administration, FDA, food

15.

Should Congress Pass Legislation to Regulate Child-Directed Food Advertising?

Food and Drug Policy Forum, Vol. 1, No. 9, 2011
Number of pages: 16 Posted: 25 May 2011
Roseann B. Termini, Thomas A. Roberto and Shelby G. Hostetter
Widener University Delaware Law School, Widener University Delaware Law School and Widener University Delaware Law School
Downloads 74 (363,863)

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obesity, children, marketing, advertising, food

16.

Pharmanex, Inc. v. Shalala: A Wake Up Call for Congress and a Not So Bitter Pill for the FDA

Ohio North University Law Review, Vol. 26, No. 2, p. 269, 2000
Number of pages: 20 Posted: 26 May 2012
Roseann B. Termini
Widener University Delaware Law School
Downloads 71 (372,250)

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dietary supplements, regulation, Food and Drug Administration, FDA, Dietary Supplement Health and Education Act

17.

50 Years Post Controlled Substances Act: The War on Drugs Rages on with Opioids at the Forefront

Ohio North University Law Review, v. 46, 2020
Number of pages: 52 Posted: 08 Aug 2019 Last Revised: 03 Feb 2020
Roseann B. Termini and Rachel Malloy-Good
Widener University Delaware Law School and Widener University - Delaware Law School
Downloads 67 (384,089)

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opioid epidemic, opioids, drug abuse, drug policy, drug law, pharmaceutical industry

18.

The Role of the Pharmacist Revisited: Should the Changing Role of Health Care Impart the Obligation of a Pharmacist to Warn?

FDLI's Food and Drug Policy Forum, Vol. 2, No. 23 (2012)
Number of pages: 24 Posted: 20 Dec 2012
Roseann B. Termini
Widener University Delaware Law School
Downloads 65 (390,241)

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food and drug law, pharmacists, duty to warn, liability, drugs

19.

Does “Political” Science Exist Anymore? Embryonic Stem Cell Research in this New Political Climate

Journal of Health & Biomedical Law, Vol. 5, p. 249, 2009
Number of pages: 33 Posted: 25 Jan 2010 Last Revised: 18 Apr 2013
Roseann B. Termini
Widener University Delaware Law School
Downloads 64 (393,302)

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stem cells, research, health law, medical research, religion

20.

Product Classification Under the Federal Food Drug and Cosmetic Act: When a Food Becomes a Drug

Journal of Pharmacy & Law, Vol. 2, p. 1, 1993
Number of pages: 14 Posted: 05 Jun 2012
Roseann B. Termini
Widener University Delaware Law School
Downloads 56 (419,981)

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food, drugs, Food and Drug Administration, FDA, consumer protection, food and drug law

21.

The Latest 'Federal Movement' in the Food and Drug Law Arena: The Federal Right-to-Try or Rather Right-to-Know and Thus Request Investigational Therapies for Individuals with a Life-Threatening Disease or Condition

Indiana Health Law Review, Vol. 16, Issue 1, November 2018
Number of pages: 31 Posted: 05 Sep 2018 Last Revised: 17 Feb 2019
Roseann B. Termini
Widener University Delaware Law School
Downloads 54 (426,999)

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pharmaceutical law, drug law, right to try, investigational drugs, terminally ill patients, experimental drugs

22.

The Influence of Culture, Government and the Law on the Use of Antidepressants for Children in the United States and Pakistan

Food and Drug Law Journal, Vol. 63. No. 3, 2008
Number of pages: 10 Posted: 12 Feb 2009
Roseann B. Termini and Christine A. Kelly-Miller
Widener University Delaware Law School and Widener University Delaware Law School
Downloads 51 (437,936)

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depression, children, antidepressants, united states, pakistan

23.

A Look Back at DSHEA — Over 25 Years Later: The Dangers of a Reactionary Approach to Dietary Supplement Regulation

Quinnipiac Health Law Journal, v. 22, no. 2 (2019)
Number of pages: 53 Posted: 04 Nov 2018 Last Revised: 09 May 2019
Roseann B. Termini and Vincent Sannuti
Widener University Delaware Law School and Widener University - Widener University School of Law
Downloads 44 (465,579)

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Dietary Supplements, Food and Drug Law, Food and Drug Administration, FDA, Regulation, DSHEA

24.
Downloads 43 (469,807)

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Tobacco Regulation, E-Cigarettes, Family Smoking Prevention and Tobacco Control Act, Food and Drug Administration, Electronic Nicotine Delivery Systems, Youth Smoking

25.

What is Pharmacy Compounding?

PBA Health Care Law Committee Newsletter, Vol. 3, No. 1, Winter 2013
Number of pages: 2 Posted: 04 Mar 2013
Roseann B. Termini
Widener University Delaware Law School
Downloads 34 (510,813)

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pharmacies, compounding, drugs, pharmaceutical industry, food and drug law, FDA

26.

'Right to Try' or 'Right to Ask:' Do State Right-to-Try Laws Offer an Answer for Terminally Ill Patients Seeking Access to Investigational Therapies?

The Pennsylvania Lawyer, Nov/Dec 2016
Number of pages: 4 Posted: 04 Nov 2017
Roseann B. Termini and Janet Lis
Widener University Delaware Law School and Independent
Downloads 33 (515,864)

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Food and Drug Law, FDA, Experimental Drugs, Pharmaceutical Industry, Investigational Drugs, Constitutional Law

27.

This Is Not 1976 Anymore — Moving Forward in Medical Device Safety and the 510(K) Clearance Process Under the United States Federal Food, Drug, and Cosmetic Act

Quinnipiac Health Law Journal, Forthcoming
Number of pages: 30 Posted: 13 May 2020
Roseann B. Termini and Julinda Hoxha
Widener University Delaware Law School and Independent
Downloads 27 (548,534)

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Medical Devices, Food and Drug Administration, FDA, Health Law

28.

Enforcement – Corporate Officer Liability – It is not a Walk in the Park and the The Foreign Corrupt Practices Act Application

Journal of Pharmaceutical Health Services Research, v. 8, 2017, Widener University Delaware Law School Legal Studies Research Paper Series No. 17-09
Number of pages: 5 Posted: 07 Jun 2017
Roseann B. Termini
Widener University Delaware Law School
Downloads 27 (548,534)

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corporate liability, mens rea, misbranded products, person, corporate officer

29.

The Impact of Filing Bankruptcy on Environmental Protection: Police Power and the Automatic Stay 11 U.S.C. § 362

Northrop University Law Journal of Aerospace, Business and Taxation, Vol. 6, p. 1, 1985
Number of pages: 17 Posted: 05 Jun 2012
Roseann B. Termini
Widener University Delaware Law School
Downloads 27 (548,534)

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bankruptcy, environmental law, Superfund, CERCLA

30.

The Legal Authority of the United States Food and Drug Administration to Regulate Tobacco: Calling on Congress

St. John's Law Review , Vol. 74, No. 1, p. 63, 2000
Number of pages: 24 Posted: 26 May 2012
Roseann B. Termini
Widener University Delaware Law School
Downloads 24 (567,100)

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smoking, cigarettes, FDA, Food and Drug Administration, regulation

31.

Constitutional Implications Triggered by the Imposition of Criminal Sanctions Under Section 268(B) of the Tax Reform Code of Pennsylvania (72 P.S. § 7268(B))

Dickinson Law Review, Vol. 96, No. 2, p. 167, 1992
Number of pages: 22 Posted: 26 May 2012 Last Revised: 15 Jun 2012
Roseann B. Termini and JoAnn Collins
Widener University Delaware Law School and affiliation not provided to SSRN
Downloads 23 (573,397)

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Pennsylvania, sales tax, criminal penalties, constitutional law

32.

Pharmacy Liability for Punitive Damages: Pennsylvania Practice Pointers

Pennsylvania Bar Association Quarterly, v. 71, no. 1 (2000)
Number of pages: 6 Posted: 19 Mar 2016
Roseann B. Termini, Joseph Wusinich and Edward Sweeney
Widener University Delaware Law School, Pennsylvania Bar Association and Pennsylvania Bar Association
Downloads 22 (579,919)

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pharmacists, pharmacies, liability

33.

Enactment of Environmental Legislation and Enforcement Through Criminal Sanctions: Pennsylvania as a Role Model

Temple Environmental Law & Technology Journal, Vol. 9, No. 1, 1990
Number of pages: 18 Posted: 05 Jun 2012
Roseann B. Termini
Widener University Delaware Law School
Downloads 15 (626,668)

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environmental law, Pennsylvania, criminal sanctions

34.

Administrative Law Overview

Regulatory Focus, August 2019
Number of pages: 8 Posted: 23 Aug 2019
Roseann B. Termini
Widener University Delaware Law School
Downloads 2 (724,447)

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administrative law, federal administrative process, Administrative Procedures Act, Food and Drug Administration, federal rulemaking, administrative procedure

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food and drug law, pharmaceuticals, Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary, Tobacco Products

Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products

Forti Publications (2014)
Posted: 14 Jun 2014
Roseann B. Termini
Widener University Delaware Law School

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food, drugs, cosmetics, FDA, Food and Drug Administration, food and drug law, medical devices, tobacco products, personal care, cosmetics

Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary, and Tobacco Products

Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary, and Tobacco Products, Forti Publications, 2017, ISBN: 978-0984356157, Widener University Delaware Law School Legal Studies Research Paper Series
Posted: 05 Sep 2017
Roseann B. Termini
Widener University Delaware Law School

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Food and Drug law, Pharmaceuticals, Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Personal Care, Veterinary, Tobacco Products

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food and drug law, cosmetics, dietary supplements, tobacco products, medical devices, biologics, drugs, pharmaceuticals, health law

Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Cosmetics, Veterinary and Tobacco Products Regulation

Forti Publications, 10th ed., 2019
Posted: 29 Apr 2019
Roseann B. Termini
Widener University Delaware Law School

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food law, drug law, pharmaceutical law, biologics, medical devices, tobacco products, dietary supplements, food and drug law

38.

Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Cosmetics, Veterinary and Tobacco Products

R. Termini, FOOD AND DRUG LAW: FEDERAL REGULATION OF DRUGS, BIOLOGICS, MEDICAL DEVICES, FOODS, DIETARY SUPPLEMENTS, COSMETICS, VETERINARY AND TOBACCO PRODUCTS, Forti Publications, 2012
Posted: 02 Feb 2012
Roseann B. Termini
Widener University Delaware Law School

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food and drug law, FDA

39.

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

Forti Publications, 4th edition, 2010
Posted: 02 Feb 2010
Roseann B. Termini
Widener University Delaware Law School

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Food, Drugs, Law, FDA, Federal Regulation, Biologics, Medical Devices, Dietary Supplements