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2 weeks ago | 
mondaq.com | Kyle Faget |Nathan Beaver |David Rosen |Monica R. Chmielewski
A Texas judge for the U.S. District Court for the EasternDistrict of Texas issued a ruling on March 31, 2025, to vacateand set aside, in its entirety, the U.S. Food and DrugAdministration's (FDA) Final Rule titled Medical Devices; LaboratoryDeveloped Tests (LDTs) (LDT Final Rule).
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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 7, 2024 | 
mondaq.com | Monica R. Chmielewski |Kyle Faget
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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Nov 5, 2024 | 
jdsupra.com | Jessica M. Boubker |Monica R. Chmielewski |Kyle Faget
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 1, 2024 | 
jdsupra.com | Monica R. Chmielewski |Kyle Faget |Olivia King
This is the fifth edition of our blog series on decentralized clinical trials DCTs. Click here to explore the series. The COVID-19 Pandemic required the health care industry to adapt to accommodate remote patient care, including for patients involved in clinical trials, and the use of Decentralized Clinical Trials (DCTs) proliferated during the Pandemic.
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Sep 25, 2024 | 
jdsupra.com | Monica R. Chmielewski |Olivia King |Lisa M. Noller
On September 17, 2024, the Office of Research Integrity (ORI) issued a final rule adopting changes to federal regulations governing research misconduct involving federally funded research (Final Rule). The regulations have not been updated since 2005 and were in need of revision to address the complexities of modern-day research.
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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 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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Feb 27, 2024 | 
jdsupra.com | Jessica M. 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.
