Category: regulatory
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Aspergillus Testing in Cannabis: Why Glass House Farms Is in the Spotlight
In recent months, a heated debate has emerged in the cannabis industry over the necessity of stringent microbial testing standards. Specifically, the testing for Aspergillus—a genus of mold that includes species such as Aspergillus niger, Aspergillus flavus, Aspergillus fumigatus, and Aspergillus terreus—has taken center stage. This debate intensified when Glass House Farms, one of California’s…
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Takeaways on SB-1012, the Latest Bill to Aim to Regulate Psychedelics in California
The quick take-away on California’s Senator Scott Weiner bill SB 1012’s passing out of the Business and Professions Committee is that we have proposed legislation that creates This development reflects momentum for increased access for psychedelics without creating a suddenly open market. Oregon just RE-criminalized psychedelics along with other drugs, after the 2020 ballot initiative…
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Ignored Risks of Drug Shortages Hiding in Plain Sight Threaten US’s Pharma Supply Chains
Navigating Challenges in Pharmaceutical Supply Chains: A Decade of Delays and a Path Forward Introduction The Drug Supply Chain Security Act (DSCSA), enacted in November 2013, was intended to transform the pharmaceutical supply chain in the United States. Despite its ambitions, the DSCSA faced another enforcement delay in November 2023, marking ten years without full…
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Six Ways White House Proposes to Bring Domestic Drug Supply Back to US
The proposal outlined in a new Biden White House white paper involves policy considerations that are estimated to cost between $3.26 billion and $5.11 billion over a span of 10 years. This funding is aimed at improving the supply of generic sterile injectable medicines and enhancing the resilience of drug supply chains.
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Biden Proposes Strategy to Combat Drug Shortages Through Supply Chain Resilience
In a move aimed at addressing persistent drug shortages and enhancing supply chain resilience, the White House recently unveiled an 18-page white paper proposing a novel strategy.
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What is FDA Marketing Approval?
FDA marketing approval refers to the authorization granted by the United States Food and Drug Administration (FDA) for a company to market and sell a specific drug, medical device, or biological product. Before a product can be legally sold in the U.S., it must undergo a rigorous review and evaluation process to ensure its safety,…