HeyJaredDominick P. DiSabatino
- Indexed articles, last 90 days
- 5
- Latest publication
- Sep 22, 2026
- Outlet visibility, for Mondaq
- Top 500K sites
- Earliest in this view
- Jul 23, 2026
Latest articles
FDA Balances Peptide Policy With Enforcement Against Unlawful Peptide Sellers (opens the original)
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Over the past year, industry has had a front row seat as the Food and Drug Administration (“FDA” or the “Agency”) decides just how much leeway it wants to afford the manufacture, marketing, and sale of peptide products, and just where it wants to draw the line. Despite the recent decision of FDA’s Pharmacy Compounding Advisory Committee (“PCAC”) to recommend a number of peptides for inclusion on the 503A bulks list process — a move that represents a potentially more permissive stance toward pept
Enhanced FDA-SEC Collaboration: How Life Sciences Companies Think About Disclosure, Insider Trading, And Prediction Markets (opens the original)
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On August 31, 2026, the U.S. Securities and Exchange Commission (SEC) and Food and Drug Administration (FDA) signed a Memorandum of Understanding (the “MOU”)[1] to “establish a framework to support the parties’ respective regulatory and enforcement responsibilities and otherwise enhance cooperation.” On its face, the document is not earth-shattering—six pages of information-sharing protocols, points-of-contact designations, and FOIA-referral procedures. But read against the backdrop of prior bio
Above The Federal Floor: How States Are Regulating Compounded GLP-1s And Peptides (opens the original)
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In our recent update on peptide regulation, we noted that the FDA is only one layer of the compliance picture. For any company with exposure to multi-state compounding or telehealth operations — whether as an operator, a brand manufacturer monitoring the competitive landscape, or an investor — a jurisdiction-by-jurisdiction breakdown of state requirements is essential. This post maps how states are currently regulating the compounding of GLP-1 receptor agonists (semaglutide and tirzepatide chief
Compounded Peptides On The Loose: What The Recent PCAC Meeting Means For Industry (opens the original)
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The pharmaceutical compounding landscape just shifted meaningfully. On July 23 and 24, 2026, the Food and Drug Administration’s (“FDA’s” or the “Agency’s”) Pharmacy Compounding Advisory Committee (the “PCAC” or the “Panel”) convened a high-profile, two-day meeting to evaluate seven unapproved peptide bulk drug substances for potential inclusion on the Agency’s so-called “503A bulks list.” When the votes were tallied, the Panel had recommended six of the seven peptides for inclusion — a result th
What To Watch: Forthcoming Limitation On DTC Pharmaceutical Ads (opens the original)
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This month, the U.S. Food & Drug Administration (“FDA”) quietly published its Unified Agenda, which includes a proposed rulemaking that — if finalized — would fundamentally reshape the landscape of prescription drug marketing in the United States. While this was not an unexpected development, companies that operate within or adjacent pharmaceutical advertising should tune in to see whether the administration can ultimately deliver on its promise to ban direct-to-consumer (“DTC”) pharmaceutical a
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