Comments are open for two weeks. Former FDA official Peter Lurie calls it a nod to MAHA voters, while Hims & Hers plans to sell wellness peptides.
Recap by typeshit. Full story at Yahoo.
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 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.
Prof Jeanne Lubbe and Discovery Health weigh in. Discovery says GLP-1 claims tripled from 2022 to 2025, with members claiming for 5.4 months on average.
Food Dive reports the Atkins brand is shifting its pitch toward lapsed GLP-1 users, a growing group food companies are now chasing.
Loading…