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...
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...
In this installment of Risk Management 360, we look at clinical trials. This article discusses how products liability that arises from a clinical trial can be mitigated with the right practices and...
In this installment of Risk Management 360, we evaluate the role of complaint handling in a robust products liability risk management protocol. This edition of the series takes a close look at how...
In this installment of Risk Management 360 explains why contracts are so important to life sciences companies and some particular legal doctrines that make the lack of contracts perilous to doing...
This installment of Risk Management 360 details the most important provisions for life sciences companies to include in their contracts and how to handle contract negotiations with limited leverage.
While the life sciences industry has long been in the practice of recalling products from the market after post-market discoveries of product defectsi, FDA’s authority to compel the recall of...
Medical device manufacturers must ensure that they have a well-designed system to address complaints related to their products.
Medical device and drug manufacturers have no intent or desire to introduce harmful devices or drugs into the marketplace.
