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.
Recap by typeshit. Full story at The National Law Review.
Experts debate how regulators should separate real patient customization from mass-produced copies, citing recent tirzepatide sterility recalls and impurity findings.
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.
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.
In a clip from their conversation, Dr Strumeier argues the scale can't show whether you're losing fat or muscle, and says keeping muscle should be part of the plan.
A clip from UCLA's Medically Speaking podcast episode on GLP-1 science and culture, covering current eligibility for the medications.
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