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Drafting Informed Consent Forms

The key objective of obtaining informed consent from a clinical trial participant is to ensure that the participant fully understands the nature and risks.

Risk Management Checklist for Safety Information for Home-Use Products

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...

Risk Management 360: Product Classification: Products Liability Implications

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...

Risk Management 360: Risk Management in Clinical Trials

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...

Risk Management 360: The Relationship Between Complaint Handling and Products Liability

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...

Risk Management 360: Contracting, Part I: Why Use Contracts?

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...

Risk Management 360: Contracting, Part II: What Should Be In Your Contract and How to Deal with Adverse Terms from the Other Side

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.

Risk Management 360: Managing Risk Through Product Recall Preparation

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...

Complaint Handling for Medical Device Manufacturers

Medical device manufacturers must ensure that they have a well-designed system to address complaints related to their products.

Defending a Products Liability Lawsuit

Medical device and drug manufacturers have no intent or desire to introduce harmful devices or drugs into the marketplace.

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