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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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 This is the third topic included in the new draft guidance.

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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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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 21, 2023

enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g.,

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FDA Law Blog

JUNE 27, 2024

Public Interest Factors The Controlled Substances Act provides that DEA may suspend or revoke a registration upon finding that the registrant has committed acts that would render the registration inconsistent with the public interest. By Larry K. 21 U.S.C. § 21 C.F.R. §§ 1306.04(a), a), 1306.06. at § 64B16-27.810(2).

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FDA Law Blog

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

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FDA Law Blog

APRIL 23, 2023

The Draft Guidance recommends that, where possible, the outcome should be assessed by individuals blinded to treatment status, which may require re-adjudication of externally controlled data. This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources.

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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. Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works.

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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

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

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New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

However, people need to understand what works best for them individually. Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories.

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FDA Law Blog

OCTOBER 28, 2021

The 18 methods of contraception listed in the guidelines are derived from a Birth Control Guide (Guide) that the FDA developed in the late 1990s to provide education around relative rates of efficacy across types of contraceptives. 300gg-13(a)(4).

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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. FDA encourages sponsors to consult patients and healthcare providers to assist in developing such strategies. by sex, age or by genetic variations).

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FDA Law Blog

FEBRUARY 22, 2022

The NIH also only accepts manufacturers into the program if they can demonstrate the ability to provide high volumes (e.g., For those accepted, the NIH provides a comprehensive team of project management and scientific experts to help the manufacturer prepare a viable EUA application. What should be done?

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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. Therefore understanding these diseases, their presentations and their evaluation is critical for emergency medicine providers. And not all IEMs are included on NBS, NBS can miss individuals with IEMs.

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GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . 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. And that’s a lot easier if all providers were X waivered too.

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FDA Law Blog

MAY 3, 2022

During the episode, Oliver provides examples of medical devices featured as part of spon-con on local news stations, and demonstrates how his team was able to buy local news time to promote “ the world’s first sexual health blanket.”). Individual results may vary.’ However, this does not mitigate the misleading impression.”.

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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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FDA Law Blog

AUGUST 21, 2023

Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.) FDA went so far as to issue a proposed rule (see our blog post here ), that ultimately went nowhere. A recent state law failure-to-warn case in the SDNY makes that very point.

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GeriPal

DECEMBER 19, 2024

This episode of the GeriPal Podcast is sponsored by the Zuckerberg San Francisco General Hospital Division of Hospital Medicine , which is committed to providing outstanding, compassionate care to all patients, advancing health equity, and fostering excellence in hospital medicine. Oh, yeah, yeah. Good artist. Really tasteful.

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FDA Law Blog

SEPTEMBER 6, 2021

Though the carve-out seems at odds with FDA’s regulations requiring generic drugs to have the “same labeling” as their RLDs, such regulations specifically provide for differences arising from carved-out, patent-protected method of use. Especially now with the utility of the use code minimized. But what is a “true carve-out?”

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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. So at our cancer center, we have physicians, advanced practice providers. Or the article that, the fast food article, to use the parlance from the blog post.

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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. PART 2: INFLATION REBATES UNDER MEDICARE PARTS B AND D.

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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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