Life Sciences Legal Insights

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Wrecking ball shattering the white wall

I came in like a wrecking ball…

Big changes are coming to HHS, FDA, and CMS. How those changes play out no...
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A New Day Coming for U.S. Biotech

After the sweeping results of the election on November 5, 2024, all sectors of business...
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Happy Veterans Day!

Take this day to reflect, honor, and remember that freedom is not free! Be sure...
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Approval in U.K. for new Alzheimer’s drug, but not approved for reimbursement in U.K. National Health Service

On October 23, 2024, the U.K. Medicines and Healthcare products Regulatory Agency announced approval of...
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UPDATE: FDA to reconsider tirzepatide shortage decision in response to litigation from Industry

On October 7, 2024, the Outsourcing Facilities Association (OFA) filed litigation against FDA in the...
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Shortage resolved for Eli Lilly’s GLP-1, tirzepatide-compounders reminded of restrictions

FDA announced on October 2, 2024 that the shortage had been resolved for Eli Lilly's...
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FDA bolsters Real World Evidence Program with new Draft Guidance

FDA continues to develop its program to integrate Real World Evidence (RWE) into the Agency's...
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Welcome to my Life Sciences Law blog

Welcome to my blog providing legal insights in the life sciences arena. It's been an...