Publications
Article
Under the Watchful Eye of the FDA: What do FDA Warning Letters Tell Us?
Kevin L. Ong, Ph.D., P.E.1; Joshua White, Ph.D.2 1 Principal Engineer, Biomedical Engineering practice, Exponent, Inc., Philadelphia, PA 2 Senior Associate, Biomedical Engineering practice,...
Insurance Considerations for Global Clinical Trials
Excerpted from the Journal for Clinical Studies, September 2009. As the number of trials being conducted in multiple countries continues to increase, sponsors must insure themselves against...
The Biomaterials Access Assurance Act
Abstract: A life sciences broker recently contacted Medmarc regarding a company that was interested in expanding into the medical device supply market. The company was under the mistaken...
IMDA: Together We're Better
Being the owner of a small, entrepreneurial company can be exhilarating. You write your own ticket, set your own direction. But it can also be daunting. After all, there are no corporate coffers...
Employee Participants In Clinical Trials
Using employees as participants in a clinical trial is one solution for keeping trials on schedule. However, their participation and recruitment is fraught with the potential for inappropriate...
The CMO Landscape: Diversifying to Meet an Evolving Industry
The CMO Landscape: Diversifying to Meet an Evolving Industry Part one of a three-part series on the Contract Development and Manufacturing industry and potential products liability and...
CMO FDA Regulation: Are CMOs Regulated by the FDA?
Are CMOs Regulated by the FDA? Part two of a three-part series on the Contract Development and Manufacturing industry and potential products liability and manufacturers E&O risks. Medical...
CMO Liability: Protect Your Business From Additional Risk
CMO Liability: Protect Your Business From Additional Risk Part three of a three-part series on the Contract Development and Manufacturing industry and potential products liability and...
Claims Case Study: Negligent Design Defect
Case Study: Negligence Claim Based on Design Defect Seasoned Experts, Swift Action Led to a Defense Verdict for Medmarc Insured EXECUTIVE SUMMARY The owner of a motorized scooter carrier...