A legal analysis follows the FDA compounding advisory committee's recommendations to the new interim route HHS has opened for pharmacies.
Recap by typeshit. Full story at JD Supra.
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.
GEN ranks the best-selling drugs by 2025 sales, and Lilly's weight loss shot outpaced names like Merck's Keytruda on growth.
Semafor looks at how little national political figures have said about what the new class of weight loss drugs means for policy.
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