The FDA issued a LHCP to notify providers that blood culture media bottles (product code MDB) are being added to the medical device shortage list. Read More (external link)...
Continue readingOutbreak Investigation of Salmonella: Cucumbers (June 2024) Read More (external link)...
Continue readingEl 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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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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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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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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