Dominick DiSabatino
- Indexed articles, last 90 days
- 3
- Latest publication
- Sep 30, 2026
- Outlet visibility, for natlawreview.com
- Top 1M sites
- Earliest in this view
- Aug 6, 2026
Latest articles
FDA Opens Applications for New Pilot to Shorten Drug Approval Times: What Sponsors Need to Know (opens the original)
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Earlier this month, FDA opened applications for a new Expedited Investigational New Drug (IND) Pilot Program (the “Program”), an initiative launched under HHS Operation TrialBlazer[i] that aims to shorten the path from IND-enabling activities to first-in-human (FIH) trials while preserving FDA’s existing safety and scientific review standards. For sponsors racing to get novel candidates into trials, this pilot may offer a different approach: a rolling, collaborative IND review process built arou
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
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