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...
May 7, 2021
Given the current climate, home-use medical devices have become increasingly important, which is reflected in their unprecedented market growth this past year. Home-use medical devices offer users the...
March 18, 2021
In this special edition webinar series, Medmarc defense panel member, Jordan Lipp, Managing Member, Childs McCune, will lead an updated discussion about the PREP Act and COVID-19 a year later and...
February 3, 2021
With the ongoing COVID-19 pandemic, a transition to the new Biden administration (including a new FDA Commissioner), and shifting control of the Senate, uncertainty remains the one constant. In this...
December 2, 2020
In this installment of Medmarc’s webinar series, Kate Klaus, an attorney and FDA specialist in our Risk Management department, will guide a discussion of the top life sciences news stories of the...
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 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...