FDA Law Blog

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Pfizer’s Petition to SCOTUS.

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The Motivated MD

OCTOBER 3, 2024

Many who follow this blog know that I reside in South Carolina. However, this is a personal finance blog, and for me, it goes beyond that. In the wake of a hurricane as devastating as Helene, tens of thousands of individuals are likely filing claims, surely totaling billions of dollars. What Can We Learn From This?

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FDA Law Blog

JULY 4, 2023

The CARES Act also provides for an administrative hearing process that may be utilized under certain conditions following the formal dispute resolution process. FDA will determine the total number of individuals who can attend the consolidated proceedings in person. This is the third topic included in the new draft guidance.

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GeriPal

MARCH 14, 2024

We also talk about the importance of a proactive approach to involving speech-language pathologists in the care of individuals early on with neurodegenerative diseases like dementia and ALS. So as you mentioned, dementia, there’s some research that show about 86% or 93% of those individuals will get that. Raele: I do. I have one.

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PEMBlog

SEPTEMBER 6, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not. 2015;34(5):812-818 Chun TH.

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FDA Law Blog

JUNE 27, 2024

to promote therapeutic appropriateness by identifying: (a) Over-utilization or under-utilization; (b) Therapeutic duplication; (c) Drug-disease contraindications; (d) Drug-drug interactions; (e) Incorrect drug dosage or duration of drug treatment; (f) Drug-allergy interactions; [and] (g) Clinical abuse/misuse.” By Larry K.

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FDA Law Blog

JUNE 21, 2023

enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., How can the FDA facilitate individuals accessing medical technologies in remote locations when they are unable or unwilling to access care in clinical settings?

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FDA Law Blog

JANUARY 26, 2022

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! In defending the complete broadcast, Lilly called out similar elements from each of the individual components as demonstrating its intent to have all three viewed sequentially.

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FDA Law Blog

APRIL 23, 2023

Because an external control can involve the use of real-world data (“RWD”), the Draft Guidance notes that this guidance is being issued to satisfy, in part, requirements from the 21st Century Cures Act on the use of real-world evidence (“RWE”) in regulatory decision-making, similar to other recent efforts in this arena that we have blogged about.

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FDA Law Blog

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

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FDA Law Blog

SEPTEMBER 20, 2021

Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage. Check back for new posts on the FDA Law Blog as our HPM colleagues take a deeper look at certain programs of interest, address topics excluded from this overview (e.g.,

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FDA Law Blog

JUNE 16, 2023

The statute confuses the issue by providing that “every individual transaction in violation of [the excessive price increase prohibition] is considered a separate violation,” making it unclear whether this is a per-day or per-transaction penalty, and, if the latter, what the transaction is.

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New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

However, people need to understand what works best for them individually. blog":{"type":"Static","pageId":"tomo1"},"./medspa-policies":{"type":"Static","pageId":"c8gi2"},"./event-list":{"type":"Static","pageId":"lmi71"},"./general-clean":{"type":"Static","pageId":"u6anc"},". Food has the power to regenerate the new you!

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FDA Law Blog

OCTOBER 16, 2024

Novartis also argued that FDA’s approval of the active ingredients in the MSN product violate active ingredient sameness requirements, as ENTRESTO is a contiguous valsartan-sacubitril-sodium complex while the generic is a physical mixture of individual sodium salts.

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FDA Law Blog

OCTOBER 28, 2021

In addition, the Department guidance states that plans and issuers must cover at no cost any FDA-approved form of contraception if recommended by an individual’s prescriber based on a determination of medical necessity (i.e., 300gg-13(a)(4).

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PEMBlog

MARCH 27, 2024

She did her MD/PhD at Columbia University, where she investigated the diagnostic utility of exome sequencing for kidney disease. Meaning that an individual must inherit two copies of the mutation, so one from each of his or her parents, to be affected. And not all IEMs are included on NBS, NBS can miss individuals with IEMs.

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FDA Law Blog

JULY 9, 2024

We’ve blogged about some of FDA’s efforts to increase diversity in clinical trials previously, and the Draft Guidance itself describes a variety of these efforts. Or maybe we will see an increased utilization of and reliance on registries and other real-world evidence to gather this information in the post-market setting.

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FDA Law Blog

FEBRUARY 22, 2022

In trial design, this type of intended use provides two opportunities to identify an individual as positive. In the meantime, if the status quo continues, it is doubtful that Americans will ever have access to the widespread OTC testing that other countries are widely utilizing.

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GeriPal

APRIL 14, 2022

So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. Janet: And Katie has a great CAPC blog too that kind of summarizes a lot of additional evidence and references online if you have access to that too. Eric: And why Under Pressure.

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FDA Law Blog

MAY 3, 2022

Individual results may vary.’ When appropriately utilized, that’s not a bad thing – elevating awareness of disease states and potential treatments helps improve patient understanding and may ultimately impact access. However, this does not mitigate the misleading impression.”.

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FDA Law Blog

AUGUST 21, 2023

Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. FDA went so far as to issue a proposed rule (see our blog post here ), that ultimately went nowhere.

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FDA Law Blog

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

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GeriPal

DECEMBER 19, 2024

So we’re going to be talking about palliative care for individuals with mental illness. Depending on your geography, who you are as an individual, the ethical parameter you’re considering. There’s a Boguts case, a patient with anorexia who utilized medical aid and dying. Oh, yeah, yeah. Good artist.

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Illness Mental Health IT Patient-Centered 101

FDA Law Blog

SEPTEMBER 6, 2021

As she did in the vacated decision, Judge Prost vehemently dissented to the Majority Opinion stating frankly: “I write in this case because far from being a disagreement among reasonable minds about the individual facts, this case signals that our law on this issue has gone awry.” Especially now with the utility of the use code minimized.

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GeriPal

SEPTEMBER 19, 2024

So, basically, with a stepped care model, the goal is to tailor care delivery to the patient’s needs while at the same time utilizing less clinician resources. Alex 21:31 Blog post, if we’re talking about the same study, was like, fast food palliative care, in and out palliative care, something like that. We’re what?

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FDA Law Blog

OCTOBER 29, 2023

Since that blog post, an important step forward was the decoupling of the coverage requirement from the FDA Birth Control Guide in the guidance provided by the Department to plans and issuers.

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FDA Law Blog

SEPTEMBER 14, 2021

The most far reaching drug pricing provision of Subtitle E is an amendment to the Social Security Act to establish a Fair Price Negotiation Program applicable to Medicare Parts B and D as well as group and individual health plans in the commercial market. The Part B rebate would exclude vaccines as well.

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FDA Law Blog

NOVEMBER 8, 2023

The rule established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by an audiologist. In some measurable ways, the rule has been a success.

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FDA Law Blog

SEPTEMBER 13, 2021

Medicare negotiation authority; encourage biosimilars and generic drug utilization). Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. Drug Price Negotiation to Benefit Medicare and Commercial Plans.

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