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The Latest in Life Science
Not Just a Claims Adjuster – A Conversation with Cynthia Khin
Recently, Magna Legal Services, a company that provides legal support and consulting services, interviewed Berkley Life Sciences Cynthia "Cindy" Khin, Life Sciences Casualty Resolution Director. The following is their conversation about Cindy’s career path and the importance of mock trials.
FDA Draft Guidance for Misinformation – Part 2
In a previous post, we discussed the FDA’s July 2024 Draft Guidance entitled "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers" (the "Draft Guidance"). The Draft Guidance suggests a purportedly voluntary pathway for drug and device sponsors, manufacturers, distributors, and other stakeholders legally responsible for the labeling of approved/cleared medical products ("firms") to respond to internet-based posts and comments in a manner consistent with existing product labeling and advertising laws.
Preventing Medical Device Shortages Through Improving the United States Sterilization Supply Chain
Both Ethylene Oxide (EtO) and gamma radiation are highly effective sterilizers for medical devices, but they face significant supply chain vulnerabilities that have already led to shortages within the United States. To mitigate these risks and bolster the sterilization supply chain, the FDA recently approved a new “Established Category A” sterilization method and implemented three key programs designed to encourage medical device manufacturers to adopt alternative methods, all within the last five years (FDA, 2024).