On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national...more
6/24/2025
/ Clinical Trials ,
Drug Pricing ,
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National Priorities List (NPL) ,
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Prescription Drugs ,
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Regulatory Oversight ,
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Regulatory Requirements
This post is the fifth in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions. Throughout this series,...more
Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more
On December 12, 2023, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (“MAPS PBC”) announced it has submitted a new drug application (“NDA”) to the FDA for the use of...more
On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions....more
7/3/2023
/ Clinical Trials ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
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Plant Based Products ,
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Prescription Drugs
DEA waivers regarding the Ryan Haight Act could play a major role in telehealth’s future.
In the first decade of the 21st century, deaths attributable to overdoses of prescription drugs saw an alarming spike in volume,...more