The Direct Doctors Difference

AUGUST 18, 2021

Looking back to 2014, when we began, there were less than 100. Doctors (and other types of “providers” of healthcare) are tasked with seeing 20-25 patients in an 8 hour day, writing notes that are geared toward insurance billing, and charging for every extra they can manage - all to make the corporate system more profitable.

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Primary Care Healthcare Insurance Government 52

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

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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Supply Chain Provider Government Complication 52

Myriad Genetics

MAY 20, 2025

It’s encouraging to see patients recognize what we, as healthcare providers, already know—that medications can be an effective option for people struggling with depression, anxiety, and other mental health conditions,” said Dr. Brown. He was elected to serve AAPOR as its Vice President, President, and Past President from 2011-2014.

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By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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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Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway.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. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.

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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. use in education, construction, art, and jewelry).

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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. Some healthcare providers may recommend an MRI or ultrasound. Datar uses cutting-edge technology to provide noninvasive, personalized treatment options.

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Diagnosis Screening IT Patient-Centered 130

FDA Law Blog

NOVEMBER 1, 2023

Indeed, recent jurisdictional developments suggest that a wide of array of stakeholders could have standing to challenge the Agency’s attempt to restrict access to commonly used LDTs, including individual laboratories, hospitals, physicians and healthcare providers who routinely use these tests, and patients who depend on them.

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FDA Law Blog

JANUARY 30, 2025

For instance, the December 2024 guidance goes beyond the 2014 Expedited Programs for Serious Conditions Drugs and Biologics guidance (the last to deal substantively with accelerated approval) to describe FDAs expectation that sponsors take a proactive approach to ensuring confirmatory trials are completed within specified timelines.

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IT Clinic Provider Patients 105

FDA Law Blog

MARCH 8, 2023

Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. Those who use eSubmitter will notice changes in the electronic 3500A template in the first week of March. This should serve as a reminder to submitters to carefully review their MDRs ahead of submission.)

Electronics 59

Electronics Manufacturing Provider Medical 59

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). Front Commun ́2020 (June 12; published online). doi:10.3389/fcomm.2020.00039

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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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Referral Relationship Government Healthcare 59

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. use in education, construction, art, and jewelry).

Medical 75

Medical Manufacturing Healthcare Government 75

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.” Granted . Rescinded .

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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.

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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

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. However, in the coming days we hope to do so and may provide our thoughts in subsequent posts. 25, 2014).

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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.” See our memo summarizing CMS’s regulation here.

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Manufacturing IT Clinic Provider 59

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 351, 355-56 (1985). But there are still a couple of possibilities lurking out there!

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Patients IT Provider Individual 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

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. Thus, it is wholly unrealistic for the Third-Party Review Program to provide any meaningful reduction in Agency workload. 2, 2014), [link]. [12]

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IT Medical Patient-Centered Provider 69

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. The investigators select the drugs they will audit.

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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. The investigators select the drugs they will audit.

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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. That analysis ( here ) shows that FDA has been largely unable to meet the mandatory statutory 90-day goal of approving or disapproving a petition.

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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. That analysis ( here ) shows that FDA has been largely unable to meet the mandatory statutory 90-day goal of approving or disapproving a petition.

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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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Family Families Patients Provider 52

Physician's Weekly

JUNE 16, 2025

MONDAY, June 16, 2025 (HealthDay News) — In a policy statement issued by the American Academy of Pediatrics and published online June 16 in Pediatrics , updated recommendations are presented for providing adolescent patients with contraceptive counseling and methods. ” Abstract/Full Text Copyright © 2025 HealthDay.

Patient-Centered 52

Patient-Centered Education Electronics Insurance 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. When to use telehealth for a sore throat Telehealth offers a convenient way to treat a sore throat and also provides guidance when you’re unsure if you need in-person care. This requires emergency treatment.

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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. 2014 Feb;103:126-133. This helps people think about how people tend to each others’ well-being in their communities as well. New York City. Soc Sci Med.

Community 52

Community Education Patient-Centered Relationship 52

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

JULY 21, 2022

So that’s a piece that I think is important for providers anywhere along that process to be asking about driving. ” Emmy: I think it’s important to recognize that many primary care providers don’t have the time to be doing really comprehensive kinds of assessments. Eric: Also from the provider standpoint.

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GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. They can’t believe it, but we come back again and again and again gently to provide that support. And so the attitude has unfortunately become like, we just don’t provide care to folks.

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Healthcare IT Community Illness 100

GeriPal

MARCH 2, 2023

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? JAGS 2022 Trends in Antipsychotic and Mood Stabilizer Prescribing in Long-Term Care in the U.S.:

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