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Author: Asebey Law

23 October
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Veteran FDA Attorney Launches Boutique Life Sciences Law Firm, Asebey Life Science Law

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in Life Science Law Blog

Firm integrates scientific knowledge and regulatory expertise to offer comprehensive legal solutions and scientific guidance to life science companies. FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Edgar J. Asebey, a seasoned attorney with over 20 years of FDA regulatory law experience, has launched Asebey Life Science Law, a boutique law firm specializing in FDA regulatory law, transactional law, and strategic advisory services for the life sciences industry. As a former scientist, biotech founder, venture capital fund advisor, and equity partner at an AM 100 law firm, Edgar is uniquely qualified to lead a firm that provides much needed regulatory guidance, enforcement defense and industry expertise to FDA-regulated...

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19 August
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Gutierrez Distributor Recalls El Servidor Corp Ground Cinnamon Because of Possible Health Risk

Posted by Asebey Law
in FDA News

Gutierrez Distributor of Passaic, NJ is recalling El Servidor Corp brand ground cinnamon because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be t Read More (external link)...

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13 August
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El Chilar HF, LLC. Expands Recall of El Chilar Ground Cinnamon Due to Elevated Levels of Lead

Posted by Asebey Law
in FDA News

El Chilar HF, LLC on 03/06/2024 issued a recall of Lots # D-300 EX1024 and F272 EX1026, contained in 127 boxes (12 bags/box) of El Chilar “Cinnamon Ground” (1.25 oz bag), because it may contain traces of lead. Further investigation indicates that the issue could be caused by a potentially adulterate Read More (external link)...

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29 July
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FDA Law and the Psychedelic Renaissance

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in Publications

By Edgar J. Asebey & James T. O’Reilly* Update Magazine, Food & Drug Law Institute (Spring 2024) On December 11, 2023, the U.S. Food and Drug Administration (FDA) received the first ever New Drug Application (NDA)[1]for a psychedelic-assisted therapy.[2] The application was filed by the Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation (PBC) for MDMA-assisted therapy for Post-Traumatic Stress Disorder (PTSD) and represents the culmination of over a decade of clinical trials by the organization. On February 9, 2024, MAPS-PBC, now known as Lykos Therapeutics, announced that FDA had accepted its NDA, granted the application priority review, and assigned a PDUFA[3]target date of August...

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15 July
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Legal Guide to the Business of Marijuana: Cannabis, Hemp and CBD Regulation

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in Publications

By Edgar J. Asebey and Guilherme Faviero  Practicing Law Institute (2024 Edition) Overview Legal Guide to the Business of Marijuana is a unique resource for lawyers who represent clients in the fast-growing legal cannabis industry. For lawyers new to representing marijuana clients, the authors provide an understanding of the definitions of marijuana and other cannabis products, as well as a review of the policy and political issues that have led to the controversy and uncertainty of the current environment. The book offers critical guidance on a wide range of interrelated topics including the complex and varying state regulation of medical and non-medical marijuana; federal...

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28 June
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The Rescheduling of Cannabis: Government Scientists Speak—Will DEA Listen?

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in Publications

By Guilherme Ferrari Faviero, Esq., MS, MPH and Edgar J. Asebey, Esq. Published by The Health Lawyer, American Bar AssociationFebruary 28, 2024 Introduction In August 2023, the U.S. Department of Health and Human Services (HHS) recommended to the U.S. Drug Enforcement Administration (DEA) that marijuana, also known as cannabis, should be rescheduled to Schedule III of the Controlled Substances Act (CSA).[1] In a 252-page recommendation,[2][JC1] [GF2]  HHS concluded that, based on a scientific review by the agency, cannabis is neither as risky or as prone to abuse as other Schedule I substances and that it has potential medical benefits. The importance of this recommendation...

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Asebey Life Science Law is a boutique law firm specializing in FDA regulatory compliance, transactional law, and advisory services for the life sciences industry.

501 E Las Olas Blvd. | Suite 300
Fort Lauderdale, FL 33301

Available by appointment only *