Brian Malkin
Subscribe to Brian Malkin's PostsBrian Malkin counsels pharmaceutical and biologic clients on Food and Drug Administration (FDA) regulatory matters and intellectual property (IP) law, with an emphasis on patent litigation. His practice at the intersection of FDA- regulated products and patent law makes him a valuable partner to drug manufacturers, biotechnology clients, medical device companies and cannabis companies as they develop new products and protect their innovations though life cycle management, bring their products to market and pursue transactional opportunities.Read Brian Malkin's full bio.
Doctor-Patient Relationships and Medical Marijuana: Where Are We Now?
By Brian Malkin on Feb 15, 2023
Posted In Employee Benefits, Health and Welfare Plans
Recently, President Joe Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act, which provides a mechanism for industry and academia to access and research cannabis (including marijuana and other cannabis-derived products) without violating the Controlled Substances Act. This legislation creates a pathway for researchers to register with the US Department of Justice to legally...
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FDA Publishes Proposed Rule on National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
By Brian Malkin and Harrison Farmer on Apr 13, 2022
Posted In Employee Benefits, Health and Welfare Plans
The US Food and Drug Administration (FDA) published its proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers on February 4, 2022. The proposed rule sets national standards for the licensing of prescription drug wholesale distributors (WDDs) and third-party logistics providers (3PLs) with the goal of strengthening the security...
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