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FDA Releases Final Guidance on Considerations for the Use of Real-World Data and Real-World Evidence
The Guidance amends the 2021 draft guidance regarding products used under an Emergency Use Authorization and use of patient-level data from third parties. On August 31, 2023, the US Food and Drug Administration (FDA or the Agency) released final guidance on “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making…
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Insurance Provider Granted Summary Judgment Based on an “Aircraft Liability Exclusion” Within Its Policy
Travelers Prop. Cas. Co. of Am. v. H.E. Sutton Forwarding Co., LLC, No. 2:21-CV-719-JES-KCD, 2023 WL 5486746 (M.D. Fla. Aug. 24, 2023) – This matter involved a petition by Travelers, seeking a declaration that it did not owe a duty to indemnify or defend its insured in a personal injury lawsuit pursuant to its “Aircraft…
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Blue Cross Blue Shield of Illinois Provides Notice of Data Breach to TTEC Healthcare Employees
On September 5, 2023, Blue Cross Blue Shield of Illinois (“BCBSIL”) filed a notice of data breach on behalf of TTEC Healthcare (“TTEC”) with the Attorney General of Massachusetts after learning that a data security incident at BCBSIL compromised information belonging to TTEC employees. In this notice, TTEC explains that the incident resulted in an…
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The Hilb Group Announces Data Breach Following Unauthorized Access to Employee Email Accounts
On November 2, 2023, The Hilb Group Operating Company, LLC (“Hilb”) filed a notice of data breach with the Attorney General of Maine after learning that an unauthorized party was able to access certain employee email accounts. In this notice, Hilb explains that the incident resulted in an unauthorized party being able to access consumers’…
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The Link Between Chemical Hair Straighteners and Health Problems: Understanding the Science
Hair straightening products have recently been linked to health problems, including uterine cancer. While this is a startling development, it also appears to have been an issue that companies like L’Oréal and Revlon could—and should—have discovered (and perhaps did discover) long ago….By: Searcy Denney Scarola Barnhart & Shipley
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Product Liability Insurance for Human Clinical Trials
Life sciences companies face unique exposures and these increase when those companies commence human clinical trials. Based on our recent webinar, this article provides an overview of how you can effectively manage product liability risk as your life science company conducts human clinical trials. We provide tips on global clinical trial product liability insurance programs…
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Israel-Hamas War: Netanyahu Appears to Rebuff Blinken’s Request for ‘Humanitarian Pauses’
Israel’s leader said any cease-fire was contingent on the release of hostages. Israel’s military confirmed a strike near Al Shifa Hospital in Gaza; the hospital’s head said it hit near an entrance, killing at least 13 people and injuring many more.
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Russia Sends Biggest Drone Barrage in Weeks, Ukrainian Officials Say
Army officials and military analysts say it is part of a campaign to wear down and probe Ukrainian air defenses ahead of winter.
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As a Teen, She Loved Video Games. Now She’s Using A.I. to Try to Quash Malaria.
Rokhaya Diagne, a 25-year-old A.I. entrepreneur in Senegal, is part of a subset of Africa’s enormous youth population that is confident technology can solve the continent’s biggest problems.
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As Gaza War Enters New Phase, Israel Faces Pressure Over Civilian Deaths
Fears are rising that the conflict could spread to the occupied West Bank, where tensions are soaring among Palestinians angered over deadly Israeli airstrikes in Gaza.
