FDA Law Blog

AUGUST 23, 2022

After two negative tests, you should consider a molecular test, or call your healthcare provider. If the third test is negative, you should test again with an antigen test, or get a laboratory molecular-based test, or call your healthcare provider. But the question is, is 80% sensitivity the right place to set the bar?

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FDA Law Blog

DECEMBER 7, 2022

In simple terms from a non-scientist, these gene therapies add functional versions of genes to patients that do not have them, and thus the idea is to have these genes function in the same way as they do in individuals without these disorders. they waned over time), even though patients would have benefited over a shorter duration?

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GeriPal

AUGUST 4, 2022

My take home from this is that while the most preferred explanation for deprescribing statins and sedative-hypnotics is one focused on the risk of side effects, we also need to individualize it to the patient and the medication that they are taking. Welcome, Ariel. Ariel: Thanks. I’m excited to be here. Kevin: Thank you. Another in JAG.

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FDA Law Blog

SEPTEMBER 19, 2023

Thus, “FTC intends to use its full legal authority” to take action “against companies and individuals that improperly list patents in the Orange Book that do not meet the statutory listing criteria.” And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue.

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FDA Law Blog

OCTOBER 13, 2024

Designed to incentivize the development of drugs for pediatric rare diseases where such development may not otherwise have occurred, vouchers may be granted for drugs for serious or life-threatening rare diseases where the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years.

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33 Charts

OCTOBER 2, 2021

According to Epic, the number of patient messages spiked 151 percent nationally from the period covering the first 11 weeks of 2020 through the end of the year. Inconsistency in care delivery So as every provider shapes her practice around MyChart, each will do it in a slightly different way. And individual practice styles are fine.

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FDA Law Blog

FEBRUARY 23, 2025

To help in evaluating device changes, manufacturers commonly refer to FDAs guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, which provides FDAs interpretation of the changes it believes could significantly affect the safety or effectiveness of a device. Notably, FDAs public WL database only goes back to 2020.

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FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. Premarket Approval or De Novo pathways).

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FDA Law Blog

MAY 8, 2023

In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g.,

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ABIM

APRIL 24, 2025

Dave, MD, MPH , inquired how stressors may contribute to candidates failing the certification examination and Dr. McDonald stated that knowledge gaps were the primary cause, though ABIM provides safeguards to reduce stress like grace periods and consideration of compassionate exemptions for extraordinary life circumstances.

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FDA Law Blog

NOVEMBER 14, 2022

The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the CARES Act. FDA stresses that the law does not provide exemptions or waivers. By Riëtte van Laack & Deborah L. Livornese — Early Nov.

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FDA Law Blog

JANUARY 2, 2025

The proposed revised rule constituted a radical change from the original definition of healthy, which focused on the presence of individual (beneficial) nutrients. In contrast, the 2022 proposed redefinition focused on food groups recommended by nutrition science and the Dietary Guidelines (DGs), 2020-2025.

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FDA Law Blog

OCTOBER 9, 2023

The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. Gaulkin & Jeffrey N. Wasserstein — The U.S.

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FDA Law Blog

NOVEMBER 6, 2022

Now, after an unfavorable HHS Office of the Inspector General (OIG) advisory opinion and two defeats in court, Pfizer has appealed the Second Circuit’s decision to the Supreme Court. At the center of Pfizer’s argument is whether an AKS violation requires corrupt intent. Background.

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FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. The term healthy, as an implied nutrient claim, was first defined by FDA in 1994.

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FDA Law Blog

JULY 10, 2023

By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Philip Won & Adrienne R. But that is only the beginning.

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FDA Law Blog

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. FDA-2020-E-1840 (July 13, 2020). FDA-2020-E-1840 (Mar. 2020) , has not yet—and to our surprise—ended up in court.

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FDA Law Blog

MARCH 4, 2024

The draft guidance provides recommendations for applicants and manufacturers about the requirements for notifications about production changes of certain finished drugs and biological products and certain active pharmaceutical ingredients (API), and outlines information FDA would like to receive in addition to the requirements.

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FDA Law Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ).

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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. Rather than modify the existing FDR guidance and issue separate guidance on consolidated proceedings, FDA has issued a single draft guidance covering both topics.

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FDA Law Blog

DECEMBER 13, 2023

Dr. Janet Maynard, Director of this Office, highlighted in the press release that “[g]enetic metabolic diseases include very rare diseases that individually affect a limited number of patients. Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.”

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FDA Law Blog

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

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GeriPal

JUNE 8, 2023

So a lot of these patients that I care for are at risk for mortality or poor prognosis in general, and wanting to know how do we still provide them with quality care without giving them too many pricks, too many titrations when it comes to insulin. Listen in to learn more! But before we do, who has a song request for Alex? Nadine: I do.

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FDA Law Blog

JUNE 22, 2023

Regarding COVID-19, Tim Stenzel, Director of CDRH’s Office of In Vitro Diagnostics, has stated that “in-home testing and home collections is a top priority” ( June 2020 FDA Virtual Town Hall ); “obviously home over-the-counter tests including rapid antigen tests are a high priority” ( February 2021 FDA Virtual Town Hall ). By McKenzie E.

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Annals of Family Medicine

NOVEMBER 20, 2024

Objective To provide a comprehensive overview of primary care use among community-dwelling persons with dementia in Quebec from 2018 to 2020. Population Studied Community-dwelling persons aged 65 and older with a prevalent diagnosis of dementia on March 1st of 2018, 2019, and 2020. 60.8%, 60.2%, and 58.8%

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FDA Law Blog

JUNE 23, 2021

For example, we know that cancer patients have a high tolerance for toxicity when offered a chance at improved survival, a risk tolerance that would not be shared by individuals suffering from the common cold. the morbidity, oftentimes irreversible and progressive, and morality associated with their condition).

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The Clinical Problem Solvers

FEBRUARY 14, 2022

[link] CPSolvers: Anti-Racism in Medicine Series Episode 14: Race, Place, and Health: Clinician and Community Perspectives Show Notes by Alec Calac February 15th, 2022 Summary: This episode highlights how racism manifests in the built environment, and how community and individual-level efforts can mitigate these inequities. Be curious.

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Medical Xpress

JUNE 16, 2025

In a study published in Nature Communications , led by researchers at National Taiwan University (NTU) and National Tsing Hua University (NTHU), scientists used the deepest-ever two-photon calcium imaging in awake mice to directly observe how individual SCN neurons respond to light. But the NTU team discovered that it is far more complex.

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The Clinical Problem Solvers

FEBRUARY 8, 2023

Pearls: In 2020, American Indian and Alaska Native (Indigenous) communities experienced the highest drug overdose mortality rate of any racial or ethnic group, also surpassing rates among the non-Hispanic white population. They can use their training and privilege to advocate for meaningful policy reform.

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The Clinical Problem Solvers

MARCH 4, 2024

She discovered narrative medicine, and to her, it was about finding and retelling individual and structural stories in antiracist ways. Listening to individual stories within the context of their structural stories is important. Sayantani became a physician since she thought it was a concrete tool for social justice.

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Medical Xpress

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Food and Drug Administration (FDA). The process could take years. Ibogaine is made from the root of a plant found in Africa. It has been banned in the U.S. Former Texas Gov.

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GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life. Is it you Lyndsay?

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GeriPal

JANUARY 30, 2025

Summary Transcript CME Summary It is a battle royale on this weeks GeriPal podcast. In one corner, weighing in at decades of experience, well known for heavy hits of bedside assessments, strong patient-family relationships, and a knockout punch of interdisciplinary collaboration, we have in-person palliative care consults. But watch out!

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GeriPal

MARCH 2, 2023

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications.

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FDA Law Blog

FEBRUARY 7, 2024

Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines.

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ABIM

JUNE 24, 2025

Gertz, MD, MACP, Chair, ABIM Hematology Board The Hematology Board , which meets twice a year and is responsible for oversight of ABIM policy and assessment in the specialty, held its spring meeting on May 2, 2025. A representative from the American Society of Hematology (ASH) joined for a portion of the meeting*.

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GeriPal

MAY 26, 2022

They argue that the current guidelines, which prioritize immunocompromised people and unvaccinated older people on the same level, should be re-done to prioritize the immunocompromised first, and additionally move up older vaccinated individuals or vaccinated persons with comorbidities. Evusheld is the latest case in point. . Emily: It is.

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