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Dec 3, 2024 | 
jdsupra.com | Nathan Beaver |Jessica M. Boubker |Kyle Faget
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 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 15, 2024 | 
jdsupra.com | Jessica M. Boubker |Kyle Faget |Judith A. Waltz
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 21, 2024 | 
jdsupra.com | Nathan Beaver |Jessica M. Boubker |Kyle Faget
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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Mar 14, 2024 | 
jdsupra.com | Jessica M. Boubker |Kyle Faget |Ilana Meyer
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 This finalized guidance replaces the draft guidance issued in 2016 and provides clarity regarding FDA’s requirements when charging payors or patients for investigational drugs.
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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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Feb 26, 2024 | 
natlawreview.com | Jessica M. Boubker
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 7, 2023 | 
jdsupra.com | Jessica M. Boubker |Monica R. Chmielewski |Daniel Costandy
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.
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Dec 6, 2023 | 
natlawreview.com | Jessica M. Boubker
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.
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Oct 11, 2023 | 
jdsupra.com | Nathan Beaver |Jessica M. Boubker |Kyle Faget
October 11, 2023 Nathan Beaver, Jessica Boubker, Kyle Faget Foley & Lardner LLP + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory developed tests (LDTs). If the proposed rule is finalized without changes, FDA will...
