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Bio

Josephine Babiarz, Esq.
Associate Professor of Pharmaceutical Sciences

Department/Office
School of Pharmacy - W321

Contact
josephine.babiarz@mcphs.edu
(P)617.735.1083


Schools
School of Pharmacy - Boston

Programs
Pharmaceutical and Healthcare Business (BS)
Pharmaceutical Sciences (BS)
Pharmacy (PharmD)

Areas of Teaching
Health Care Delivery
Health Insurance and Administration
Regulatory Affairs
Law and Health Policy


Peer-Reviewed Articles & Book Chapters
Babiarz, Josephine C., Device Safety - Are Changes Coming?, Drug Development, 2009, Vol. 3, Issue 1 (Touch Briefings; www.touchbriefings.com/cdps/cditem/cfm?NID=3227). This article addresses recent laws and court decisions which are changing FDA's methods of evaluating device safety, and interprets current laws and regulations on these points.

Babiarz, Josephine C., A Primer of Drug/Device Law - or What's the Law and How Do I Find It?. In Pisano, Douglas J. and Mantus, David, eds. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics; 2nd ed, New York: CRC Press LLC, 2008; 369-395.

Babiarz, Josephine C., Pisano, Douglas J., Overview of Drug Development and the FDA. In Pisano, Douglas J. and Mantus, David, eds. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics; 2nd ed, New York: CRC Press LLC, 2008; 1-32.

Babiarz, Josephine C., Monahan, Charles III, The New Drug Application. In Pisano, Douglas J. and Mantus, David, eds. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics; 2nd ed, New York: CRC Press LLC, 2008; 69-108.

Babiarz, Josephine C. , A Learner-Centered Exercise, Teaching the History and Social Aspects of Pharmacy, Issue #9, Fall 2005; a newsletter of the American Institute of the History of Pharmacy.
Babiarz, Josephine C., Tort Limitations and the Pharmaceutical Industry; Focus Magazine published by the Regulatory Affairs Professionals Society, June 2004

Babiarz, Josephine C., What Role Should Regulators Play in Negotiating Contracts?" Focus Magazine published by the Regulatory Affairs Professionals Society, January 2005.

Babiarz, Josephine C., The Principles of Individual Sovereignty; Focus Magazine published by the Regulatory Affairs Professionals Society, April 2004.


Current Professional Memberships, Service & Leadership
Sigma Xi - Scientific Research Society
Member, Editorial Board, Drug Information Journal
Member, Massachusetts Bar Association