In part one of this video interview, Ron Lanton III, Esq., partner, Lanton Law, discusses how a potential increase in drug costs could affect the clinical research industry.
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On May 5, 2025, President Donald Trump signed the Executive Order on Improving the Safety and Security of Biological Research, marking a pivotal shift in U.S. biosecurity policy. This directive halts federal funding for "dangerous gain-of-function" (GoF) research, particularly in countries like China and Iran, where oversight is deemed insufficient. The move responds to concerns that such research—enhancing pathogens' transmissibility or virulence—could lead to lab accidents with catastrophic consequences, as speculated in the origins of COVID-19.
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The FDA has just released draft guidance in the Biden Administration’s effort to encourage the industry to enhance clinical trial diversity.
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On September 21st the FDA closed its comment period related to cannabis. Back in July the Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.”
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