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The key objective of obtaining informed consent from a clinical trial participant is to ensure that the participant fully understands the nature and risks.
In this installment of Risk Management 360, we set the stage for discussions of specific risk mitigation strategies to come. This article explores the relationship between FDA oversight of medical...
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 manufacturers...
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 manufacturers...
The United States is widely regarded as the most litigious country in the world―and for good reason.
There are a couple of other elements complicating the products liability litigation landscape for life sciences companies that deserve consideration.
Being the recipient of a lawsuit is unsettling and disruptive to any company. Not only can it be expensive to defend against, but the process can be complex.
The tripartite relationship describes the dynamic between an insurer, an insured, and a defense attorney hired by the insurer to defend the insured.
Any number and variety of crises can threaten a life sciences company and ultimately interrupt its operations, its bottom line, and damage its brand reputation.
Imagine you learn of a serious adverse event that involves your product.