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Dec 2, 2024 | 
natlawreview.com | Jessa Boubker |Kyle Faget |Eric Troutman |Kevin Spencer
On November 6, 2024, a Texas state district court jury found that a large e-discovery vendor violated Title 7, Chapter 33 of the Texas Penal Code, which provides that accessing a computer without its owner’s permission is a Class B misdemeanor. This case highlights the importance for e-discovery vendors of considering data privacy and security requirements in the course of discovery proceedings.
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Dec 2, 2024 | 
natlawreview.com | Jessa Boubker
Brand companies who own GLP-1 products have been pushing the Food and Drug Administration (FDA) to limit their compounding. On August 28, 2024, Eli Lilly and Company submitted a nomination to request that its GLP-1 product, tirzepatide, be added to FDA’s Demonstrable Difficulties for Compounding (DDC) lists.
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Nov 25, 2024 | 
appliedclinicaltrialsonline.com | Jessa Boubker |Monica R. Chmielewski |Kyle Faget
Decentralized clinical trials (DCTs) are clinical trials in which some or all trial-related activities occur at locations other than traditional clinical trial sites, such as via telemedicine or in a clinical trial participant’s home.
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Nov 5, 2024 | 
natlawreview.com | Jessa Boubker
Antibody Drug Conjugates (ADCs) are a class of small molecule drugs (also known as a payload) and an antibody conjugated together by a chemical linker. ADCs are designed to target specific cells, such as cancer cells, while minimizing the impact on non-targeted, healthy cells. The goal of ADCs is to maximize efficacy and minimize systemic toxicity.
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Oct 14, 2024 | 
natlawreview.com | Jessa Boubker
The Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET), effective August 12, 2024, to provide “transparent, predictable, and expedited national coverage” for eligible devices designated as “breakthrough devices” by the U.S. Food & Drug Administration (FDA).
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May 20, 2024 | 
natlawreview.com | Jessa Boubker
On May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed tests (LDTs). The final rule is effective July 5, 2024. The final rule amends FDA’s regulations to clarify that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory.
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May 9, 2024 | 
mondaq.com | Jessa Boubker |Monica R. Chmielewski |Kyle Faget |David Golub
Artificial intelligence continues to be one of the most talked
about business trends. Many of the AI technologies that health care
and life sciences companies are adopting are largely untested from
a legal perspective, creating gray areas that regulatory agencies
are grappling with. AI innovations also offer opportunities for
competitive advantage through the strategic management of
intellectual property rights.
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Mar 19, 2024 | 
mondaq.com | Ilana Meyer |Jessa Boubker |Kyle Faget
In February 2024, the U.S. Food and Drug Administration (FDA)
published its finalized guidance concerning its
investigational drug charging regulations (found at 21 C.F.R.
§ 312.8). These regulations are applicable to investigational
drugs being used in a clinical trial under an investigational new
drug application (IND). This finalized guidance replaces the draft
guidance issued in 2016 and provides clarity regarding FDA's
requirements when charging payors or patients for investigational
drugs.
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Mar 6, 2024 | 
mondaq.com | Jessa Boubker |Monica R. Chmielewski |Kyle Faget
In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical trial participant's cost-sharing obligations (i.e., copayments, coinsurance, and deductibles) – even though such subsidization would generate prohibited remuneration under the Federal anti-kickback statute (AKS) and such subsidization would generate prohibited remuneration...
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Dec 13, 2023 | 
mondaq.com | Daniel Costandy |Jessa Boubker |Monica R. Chmielewski
The U.S. Food and Drug Administration (FDA) has demonstrated a
commitment to expanding diversity in clinical trials. Decentralized
Clinical Trials ( DCTs) contribute to this effort by enhancing
convenience for trial participants, reducing burdens on caregivers,
expanding geographic access, and facilitating research on rare
diseases and diseases affecting populations with limited
mobility.
