James P. Walters, J.D., M.S. 

Medical Device & Pharmaceutical Consulting

P.O. Box 7254
Westchester, IL 60154-7254

ph: 708/343-8741
fax: 708/343-8841

Resources

Consultant

James O'Donnell PharmD MS FCP ABCP CNS FACN R.Ph.

Dr. O'Donnell is a Pharmacologist, Pharmacist and Nutritionist in Barriington, Illinois.  His carreer has included Pharmacy Practice in a variety of settings, and consultations to industry, government, health care, publishing and legal fields.  He is currently an Associate Professor Pharmacology at Rush Medical College in Chicago, and a Diplomate of the American Board of Clinical Pharmacology.  He consults and testifies in matters involving pharmaceuticals, medication errors, alcohol and drug injuries for defense and plaintiff's counsel.  www.pharmaconsultantinc.com

Publications

Walters, J.P. "Guidance to Clinical investigators on Responding to FDA Warning Letters."  The Monitor 18.1 (2004): 29-32*

Walters, J.P. "Food & Drug Administration Regulation of Clinical Investigators."  Drug Injury: Liability, Analysis and Prevention, 2nd Ed., James T. O'Donnell, Editor, Lawyers & Jundges Publishing Company, Inc., 2001**

*Reprints available by request.  Please call or e-mail

**Table of contents available at www.pharmaconsultantinc.com

P.O. Box 7254
Westchester, IL 60154-7254

ph: 708/343-8741
fax: 708/343-8841