PEMBlog

OCTOBER 31, 2024

Caution While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts. However, for pediatric gastroenteritis, the evidence suggests they do not provide significant benefits. 2018 Nov 22;379(21):2002-2014. N Engl J Med. doi: 10.1056/NEJMoa1802598. Freedman et al.

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FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Clinic Clinical Practice Provider Utilities 64

FDA Law Blog

JUNE 30, 2022

As the drug distribution industry is well aware, and as blogged about here , on February 4, 2022, FDA published its long-awaited proposed rule titled “ National Standards for the Licensure of Wholesale Drug Distributors and Third-party Logistic Providers ” (87 Fed. 2) State regulation of third-party logistics providers. 6,708 (Feb.

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AMMD

FEBRUARY 14, 2025

My first breast cancer scare was in 2014, when they discovered calcifications for the first time during a routine mammogram. Additionally, it’s classified as stage 0, so it’s not nearly as scary as conventional medicine leads us to believe. In fact, I had a similar situation happen to me not too long ago. In 2024, I had another scare.

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FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. However, the 2014 Guidance cannot be ignored entirely.

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FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. This guidance document is still in effect today.

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FDA Law Blog

NOVEMBER 1, 2023

In fact, stakeholders have repeatedly challenged FDA’s assertions of authority in Citizen Petitions, public comments, and other forums. Premarket Approval or De Novo pathways). In support for this position, FDA states that hospitals that reprocess single-use devices have been viewed as manufacturers and points to its own webpage for support.

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FDA Law Blog

AUGUST 12, 2024

Plaintiffs performed the necessary studies on BRAVECTO and filed an NADA on April 8, 2014; FDA approved the NADA on May 15, 2014. s Motion for Summary Judgment finding that FDA failed to provide fair notice to plaintiffs of the need to submit an NCIE rather than an INAD to trigger the start of the testing phase.

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FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. This guidance document is still in effect today.

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FDA Law Blog

MAY 7, 2025

The Seventh Circuit took a more lenient approach than the Fourth Circuit, focusing its rationale on whether an independent contractor had improper influence over a healthcare providers independent healthcare decisions. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th

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FDA Law Blog

JUNE 29, 2022

In May 2014, FDA finalized a guidance document entitled “ Expedited Programs for Serious Conditions – Drugs and Biologics ,” (the Expedited Programs Guidance) This guidance noted that a “[d]esignation may be rescinded if it no longer meets the qualifying criteria for breakthrough therapy.”

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IT Clinic Provider Medical 52

BMJ

JULY 17, 2020

As previous research has found, providing factual information helps tremendously in addressing misconceptions and myths about infectious diseases, the latter of which can seriously undermine implementation of preventive measures. 2014 (28 August). National involvement is also needed to facilitate these efforts. doi:10.3389/fcomm.2020.00039

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Community Individual Physicals Finance 40

FDA Law Blog

SEPTEMBER 13, 2022

The final guidance with the same title (Guidance), which we blogged about here at the time of release in 2014, provided additional clarity, but we find that, even with years of experience, it is still a challenge in many cases to decide how best to bring a second device into a substantial equivalence discussion.

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IT Medical Provider 52

FDA Law Blog

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. FDA-2022-E-3124 ).

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Clinic IT Provider Patient-Centered 59

FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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IT Medical Patient-Centered Provider 69

FDA Law Blog

JUNE 23, 2021

This is why it is important for relevant patient populations to provide input as to what degree of certainty is needed for there to be a fair and reasonable conclusion of drug benefit for their condition. the morbidity, oftentimes irreversible and progressive, and morality associated with their condition).

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Patients Patient-Centered Clinic IT 52

FDA Law Blog

APRIL 3, 2023

Over ten years after this statutory amendment, on December 31, 2020, CMS finalized a broad definition of “new formulation” as “any change to the drug, provided that the new formulation contains at least one active ingredient in common with the initial brand name listed drug.” NDA or BLA) drugs. See our memo summarizing CMS’s regulation here.

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Manufacturing IT Clinic Provider 59

FDA Law Blog

JUNE 14, 2022

Though Esai’s Fycompa was initially approved in October 2012, it wasn’t scheduled until January 2014, meaning that Esai lost a little more than a year of patent life awaiting scheduling—in addition to the time spent in regulatory development and review.

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IT Provider Medical 52

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. In September 2014—nearly ten years ago!—PTE leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”).

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Patients IT Provider Individual 59

FDA Law Blog

MAY 20, 2021

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. Policies and Procedures.

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Management Consulting Provider Physicals 40

FDA Law Blog

MAY 20, 2021

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. Policies and Procedures.

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Management Consulting Provider Physicals 40

FDA Law Blog

APRIL 30, 2021

Indeed, back in 2014, we put together a review of more than 1,300 ANDA Suitability Petitions submitted to FDA since the enactment of the 1984 Hatch-Waxman statutory provision creating them. While we’re pretty excited about the changes both bills would make to the law, we’re particularly stoked about S. According to the press release on S.

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IT Clinic Government Provider 40

FDA Law Blog

APRIL 30, 2021

Indeed, back in 2014, we put together a review of more than 1,300 ANDA Suitability Petitions submitted to FDA since the enactment of the 1984 Hatch-Waxman statutory provision creating them. While we’re pretty excited about the changes both bills would make to the law, we’re particularly stoked about S. According to the press release on S.

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IT Clinic Government Provider 40

CDOCS

MARCH 26, 2021

png]<br /> <em><span style="font-size:11px;">​Figure& 1:& <span data-contrast="auto" xml:lang="EN-US">A life-long bruxer, this patient presented with lost teeth in the posterior and compensatory eruption of lower anterior teeth.</span>& png] [image:10.png]​<br

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Families Family Patients Provider 52

Common Sense Family Doctor

FEBRUARY 1, 2025

Since the turn of the century, the rise of hospitalists and the corresponding decline in the number of office-based family physicians who provide inpatient care for their own patients has magnified the value of optimizing the handoff from hospital-based teams to primary care physicians.

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Hospital Management Primary Care Primary Care Physician 52

Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. Most sore throats are common cases, so it can be hard to know when to seek urgent care or when to just rest at home. Swollen neck Neck swelling may suggest an infection spreading into deeper tissues.

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ER Telehealth Primary Care Doctor Appointment 52

The Clinical Problem Solvers

MARCH 4, 2024

It also helps illustrate the power of witnessing and mutual recognition, where there is a narrative exchange between patient and provider, with a validation of patients’ suffering. Sayantani became a physician since she thought it was a concrete tool for social justice. Stories are not inherently just.

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Community Education Patient-Centered Relationship 52

GeriPal

OCTOBER 24, 2024

This is back in, I don’t know, like 2014 maybe. Summary Transcript CME Summary Cannabis is complicated. It can mean many things, including a specific type of plant, the chemicals in the plant, synthetic analogs, or products that have these components. I am super excited to have you on, Eloise. Eloise 00:59 Thank you so much.

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Medical IT Patient-Centered Healthcare 100

GeriPal

JULY 21, 2022

Because I don’t think we think about that so much in palliative care, but we do in geriatrics. But I believe before we start, somebody has a song request for Alex. Is it you, Emmy? Emmy: It is. Eric: What’s the song? Emmy: I just forgot the name of the song… [laughter]. Alex: Pink Cadillac by Bruce Springsteen? I like that song.

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IT Families Family Diagnosis 102

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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Patient-Centered IT Healthcare Medical 96

FDA Law Blog

JUNE 7, 2021

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. It is noteworthy that this sentence that no clinical benefit has been established was deemed by FDA as unnecessary for Aduhelm to provide additional context beyond that the approval is based on reduction in amyloid beta plaques. What do we mean?

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Clinic IT Private Practice Utilities 98

GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. Today we discuss: What is the best terminology? Homelessness? Marginally housed? What makes palliative care for people experiencing homelessness challenging? What makes it rewarding? those experiencing homelessness).

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Healthcare IT Community Illness 102

GeriPal

AUGUST 25, 2022

Eric: Whenever I hear about for-profit, non-for-profit, the differences between them, mostly everybody turns to, I think, your 2014 paper looking at the differences between for-profit and non-for-profit. We’re going to be talking about each one of these papers. But before we do, I think somebody has a song request. Is it you, Melissa?

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Families Family IT Patients 107

GeriPal

APRIL 10, 2025

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. I went into emergency medicine to act. I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. They got training in Vital Talk and ELNEC. They got feedback. So did it matter?

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Patient-Centered IT Hospital Patients 78

GeriPal

FEBRUARY 2, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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Consulting Hospital Patient-Centered IT 122

PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. Available from: [link] Rice GM, Steiner RD.

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