Tag Archives: FDA

Peptides Rally: What’s New on the Regulatory Landscape for the Body’s Super Signalers

Peptides Rally: What’s New on the Regulatory Landscape for the Body’s Super Signalers

Peptides are powerhouses, the body’s versatile amino chains that play a part in tissue repair, hormone release, collagen production, metabolism optimization, infection fighting, and so much more. Yet even as science uncovers myriad therapeutic and cosmetic applications for these microscopic miracle workers, peptides remain highly regulated. That may be about to change.

An FDA advisory panel is set to meet in late July to determine the fate of seven peptides that are now restricted due to safety concerns, possibly expanding access and allowing compounding that will make the health and anti-aging properties of peptides legally available in the US. The FDA will also review five additional peptides by early 2027, and approvals are expected to pave the way for exciting breakthroughs in the health and longevity community.

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The FDA Removes Its Black Box Warning on Hormone Therapy: What Does It Mean for Longevity?

After more than two decades, the U.S. Food and Drug Administration (FDA) is initiating the removal of broad “black box” warnings from hormone replacement (HRT) products for menopause. The decision to update the FDA’s position follows a comprehensive review of the scientific literature, an acknowledgement of the expert panel’s findings in July, and a public comment period.

Now, the agency is collaborating with companies to update product labeling to remove references to the risks of cardiovascular disease, breast cancer, and probable dementia, acknowledging that HRT’s risks are not uniform—they vary based on patient factors, delivery method, and formulation.

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FDA Recommendations for Promoting Diversity in Clinical Trial Enrollment 

Over the past few decades, the United States Food and Drug Administration (FDA) has been actively working to promote inclusive enrollment practices aimed at making clinical trials more reflective of the general population; they have also focused on including a larger proportion of demographics most likely to use the medications if approved. Despite broadening eligibility criteria, challenges to participation in clinical trials remain as does widespread under-representation of several racial demographics. 

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