Lanton Law Talks to Applied Clinical Trials About How FDA Cuts Are Creating New Bottlenecks in Clinical Operations
In Part 2 of the interview; Ron Lanton, partner, Lanton Law, talks FDA layoffs and their impact on inspections and clinical trial timelines. The interview can be seen here.
In Part 2 of the interview; Ron Lanton, partner, Lanton Law, talks FDA layoffs and their impact on inspections and clinical trial timelines. The interview can be seen here.
Lanton Law Talks to Applied Clinical Trials About The Hidden Impact of Drug Pricing on Government Clinical Trials
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.
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. The interview can be seen here.
Healthcare Compliance Alert: Navigating the New Biological Research Safety Mandates
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.
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.
The order mandates the Office of Science and Technology Policy (OSTP) to collaborate with federal agencies to:
Cease funding for high-risk GoF research abroad.
Suspend ongoing domestic projects involving dangerous pathogens.
Develop a comprehensive oversight framework within 120 days.
Implement stringent compliance clauses in federal research contracts.
Healthcare entities engaged in biomedical research must now navigate a complex regulatory landscape. Compliance isn't optional; it's imperative. Institutions must audit current projects, reassess collaborations, and ensure alignment with the forthcoming policies.
At Lanton Law, we specialize in guiding healthcare organizations through regulatory transformations. Our expertise ensures that your research initiatives remain compliant and ethically sound. To understand how this executive order impacts your operations and to develop a proactive compliance strategy, contact us today.
FDA Releases Draft Guidance To Encourage Enhancing Clinical Trial Diversity
The FDA has just released draft guidance in the Biden Administration’s effort to encourage the industry to enhance clinical trial diversity.
The FDA has just released draft guidance in the Biden Administration’s effort to encourage the industry to enhance clinical trial diversity.
The purpose of this guidance is to provide recommendations to sponsors developing medical products2 on the approach for developing a Race and Ethnicity Diversity Plan (henceforth referred to as the “Plan”) to enroll representative numbers of participants from underrepresented racial and ethnic populations in the United States, such as Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of color, in clinical trials.3 Individuals from these populations are frequently underrepresented in biomedical research despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population.
Adequate representation of these populations in clinical trials and studies supporting regulatory submissions helps ensure that the data generated in the development program reflect the racial and ethnic diversity of the population expected to use the medical product if approved, and may potentially identify effects on safety or efficacy outcomes that may be associated with, or occur more frequently within these populations.
The draft guidance can be found here.
Lanton Law is a national healthcare and life science boutiquelaw andgovernment affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our life sciences practice can help stakeholders understand what’s at issue so that we can help our valued clients reach their goals.Contact us to learn about how either ourlegal orlobbying services can help you attain your goals.
FDA Cannabis Draft Guidance Comment Period Closes
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.”
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.”
This draft guidance outlined FDA's current thinking on several topics relevant to the development of cannabis and cannabis-derived products: The source of cannabis and cannabis-derived compounds for clinical research; general quality considerations for developing drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 tetrahydrocannabinol (THC) in botanical raw materials, extracts, and finished products. This draft guidance had been developed to help support clinical research into development of cannabis and cannabis-derived products.
Additional information on the draft guidance can be found here.
Lanton Law is a national boutique law and government affairs firm that focuses on healthcare/life sciences and technology. Specifically we have expertise in cannabis and CBD related issues.
If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today!