Publications
Supply Chains (2)
Component Parts and Raw Materials, Successors, and Distributor Liability
Introduction Now that we have discussed the four main theories of liability that can arise when selling a product – manufacturing, design, warnings and instructions, and marketing...
Battle of the Forms and Contracts
Question:What is the "battle of the forms" and how can life sciences companies benefit from using contracts? Answer: The “battle of the forms” refers to a method of determining...
Minimizing Risk When Obtaining Informed Consent
Compliance with FDA regulations is only the first step in minimizing the risk associated with the informed consent process. This article provides an overview of requirements and several...
Controlling Your Supply Chain
Question:What lessons can manufacturers learn from the heparin contamination crisis? Answer: Heparin, an injectable drug still in wide use as an anticoagulant (blood thinner),...
