Austin LaRoche on Muck Rack

Austin LaRoche

Washington, D.C.
As seen in: Ropes & Gray LLP, Law360, JD Supra, Mondaq, Westlaw Today, Qrius
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Articles

FDA Framework For Personalized Therapies Raises Questions

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By Joshua Oyster, Beth Weinman, Austin LaRoche
| Law360 Verified
By Joshua Oyster, Beth Weinman and Austin Laroche ( March 20, 2026, 6:06 PM EDT) -- On Feb. 23, the U.S. Food and Drug Administration issued a highly anticipated draft guidance that details a new regulatory approach — the plausible mechanism framework — for the development of individualized therapies.... Law360 is on it, so you are, too. A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence.
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Rare Disease in Focus at FDA: New Draft Guidance on Plausible Mechanism Framework for Individualized Therapies

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By Austin LaRoche, Jessica Bushman
| JD Supra
On February 23, 2026, FDA issued a highly anticipated draft guidance entitled “Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause” (“Draft Guidance”).
Open in Who Shared Issue with article?

Rare Disease in Focus at FDA: New Draft Guidance on Plausible Mechanism Framework for Individualized Therapies

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By Beth Weinman, Joshua Oyster, Austin LaRoche
| Westlaw Today Verified
On February 23, 2026, FDA issued a highly anticipated draft guidance entitled "Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause"...
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