The recall came after an FDA warning letter. The Regulatory Review uses it to dig into how compounded GLP-1s stayed on sale after shortages officially ended.
Recap by typeshit. Full story at The Regulatory Review.
Experts debate how regulators should separate real patient customization from mass-produced copies, citing recent tirzepatide sterility recalls and impurity findings.
A legal walkthrough of the 503A rules behind the October 28 policy, the July advisory vote, and the HHS note that it may revisit the policy if safety signals appear.
The peptide item sits among gene therapy, Neuralink and Medicare news. The Alliance for Safe Biologic Medicines has asked HHS to pause the policy, citing FDA scientists.
Maria David Patten alleges Novo hid NAION risks; her case joins the federal MDL before Judge Karen Marston in Pennsylvania, where bellwether trials are expected.
Tara Wider has spent about five years posting on holistic beauty and women's wellness, building a following of women her age on social media.
Experts flag NSAIDs, Benadryl and combo remedies as trickier picks during illness on a GLP-1, and say hydration and pausing doses deserve a talk with your provider.
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