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FDA Evaluation of Certain Bulk Drug Substances in Compounding: Clinical Interpretation
Clinicians increasingly encounter patients using or requesting peptide-based therapies sourced through compounding pharmacies. The U.S. Food and Drug Administration has ...
Semaglutide and the Expansion Problem: When One Trial Becomes a Platform
Semaglutide has moved beyond its original indication and now sits at the center of a widening set of clinical questions: ...
Glucagon-Like Peptide–Based Therapies and Longevity: Clinical Implications from Emerging Evidence
Glucagon-like peptide–based therapies are increasingly used for weight management and glycemic control, but their potential impact on long-term survival remains ...
BIIB080 in Mild Alzheimer’s Disease: What a Phase 1b Exploratory Clinical Analysis Can—and Cannot—Tell Us
Can lowering tau biology translate into a clinically meaningful slowing of decline in people with early symptomatic Alzheimer’s disease? That ...
Ambient Artificial Intelligence Clinical Documentation: Workflow Support with Emerging Governance Risk
Health systems are increasingly deploying ambient artificial intelligence tools that listen to clinical encounters and automatically generate draft visit notes. ...
What the Most-Cited LLM-in-Medicine Papers Reveal—and What They Miss
In just over two years, papers on large language models (LLMs) in medicine have accumulated nearly fifteen thousand citations, creating ...
Analysis of the DHHS “Real Food” Initiative
EXECUTIVE SUMMARY The Department of Health and Human Services has launched a transformative public health initiative through the RealFood.gov platform, ...
Official MAHA Report
Explore the official MAHA Report released by the White House in May 2025.
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FDA Evaluation of Certain Bulk Drug Substances in Compounding: Clinical Interpretation
Clinicians increasingly encounter patients using or requesting peptide-based therapies sourced through compounding pharmacies. The U.S. Food and Drug Administration has identified a subset of bulk drug substances, including certain peptides, that may present significant safety risks when used in compounded formulations. The clinical question is whether these regulatory signals reflect meaningful patient-level risk and how they should influence prescribing behavior. This matters because compounded peptides often sit outside traditional approval pathways, creating uncertainty around quality, dosing consistency, and safety. Understanding...
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