With the dissolution of the U.S. Department of Justice’s Consumer Protection Branch set to occur by Sept. 30, a vital question that remains to be fully answered is who will be responsible for litigation matters typically...more
8/18/2025
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On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more
1/16/2025
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Trade Secrets
Brand companies who own GLP-1 products have been pushing the Food and Drug Administration (FDA) to limit their compounding. On August 28, 2024, Eli Lilly and Company submitted a nomination to request that its GLP-1 product,...more
On October 2, 2024, the U.S. Food and Drug Administration (FDA) determined the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved”. The tirzepatide injection had appeared...more