FDA Law

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Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway.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.

Clinic 64

Clinic Relationship Provider IT 64

FDA Law

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E.

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here.

Electronics 59

Electronics Manufacturing Provider Medical 59

AMMD

FEBRUARY 14, 2025

My first breast cancer scare was in 2014, when they discovered calcifications for the first time during a routine mammogram. For this reason, medical experts classify DCIS as noninvasive. This is why conventional physicians treat DCIS in patients with surgery, radiation, and sometimes chemotherapy. What Causes DCIS?

Diagnosis 130

Diagnosis Screening IT Patient-Centered 130

FDA Law

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.

IT 105

IT Clinic Provider Patients 105

FDA Law

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. Walsh & Sophia R. Gaulkin & Steven J. This scrutiny was enhanced after the Fourth Circuits ruling in United States v. Mallory , 988 F.3d

Referral 59

Referral Relationship Government Healthcare 59

FDA Law

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

BMJ

JULY 17, 2020

7 Moreover, medical professionals, health practitioners, and relevant academic institutions should proactively disseminate creditable news and information during such health outbreaks through mainstream social media channels. How to reduce the negative psychological impact MRSA isolation on patients. 2014 (28 August).

Community 40

Community Individual Physicals Finance 40

FDA Law

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.

Clinic 59

Clinic IT Provider Patient-Centered 59

FDA Law

DECEMBER 11, 2023

6] It is inconsistent to say that LDTs must be regulated as medical devices because of the newness of the tests and then reduce the cost of the proposed regulation by declaring that half of all LDTs will be exempt from premarket review. That seems very unlikely to be the case, because exemptions apply only to well-established tests.

IT 69

IT Medical Patient-Centered Provider 69

FDA Law

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). PTE applications were submitted to FDA for each of U.S.

Patients 59

Patients IT Provider Individual 59

GeriPal

OCTOBER 24, 2024

If you believe the evidence for efficacy to manage symptoms like neuropathic pain, how do you even start to think about recommending these products to patients? laughter] Alex 01:39 Material here for songs related to medical marijuana or marijuana in general. This is back in, I don’t know, like 2014 maybe.

Medical 98

Medical IT Patient-Centered Healthcare 98

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

Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. In fact, most sore throat symptoms resolve in three days for 60-70% of patients, according to March 2025 UpToDate, an evidence-based clinical decision support system used by healthcare professionals.

ER 52

ER Telehealth Primary Care Doctor Appointment 52

The Clinical Problem Solvers

MARCH 4, 2024

Together, our guests offer context around how the medical and carceral systems are deeply intertwined and go hand-in-hand. Explain the significance of abolition medicine, and the role of the medical system in upholding and perpetuating carceral logics.

Community 52

Community Education Patient-Centered Relationship 52

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. It’s not a controlled substance medication. Tasce: Yes. Taylor Swift.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

JULY 21, 2022

Initially, it was just because there weren’t really answers for my patients. Emmy: But we know that physiologic changes with aging, like decreasing night vision and so forth, as well as medications, as well as medical conditions, can all affect whether you can drive. “When can I get back to driving?”

IT 102

IT Families Family Diagnosis 102

GeriPal

AUGUST 25, 2022

Second, Hospice was originally designed for patients with advanced cancer, but the fastest growing admitting diagnosis is dementia. Krista Harrison found , to her surprise, that caregivers of people with dementia who died rated hospice as well as similar patients without dementia who died on hospice. AlexSmithMD. Transcript.

Families 106

Families Family IT Patients 106

GeriPal

APRIL 10, 2025

I asked emergency medicine clinicians what they thought when a patient who is seriously ill and DNR comes to the ED, and some responded, (paraphrasing), what are they doing here? 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.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

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.

Consulting 59

Consulting Individual Families Family 59

GeriPal

MARCH 6, 2025

link] Toronto Star Feature [link] CityNews Toronto Feature [link] Psychosocial Interventions at PEACH In addition to medical care, PEACH also runs two key psychosocial interventions for our clients: PEACH Grief Circles Structured spaces for workers in the homelessness sector to process grief. those experiencing homelessness).

Healthcare 100

Healthcare IT Community Illness 100

PEMBlog

JUNE 5, 2024

Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. 2014 May;133(5):e1179-88. The most common injuries seen in these younger patients are growth plate fractures and ligamentous injuries. MMWR Recomm Rep. 2012 Jan 13;61(RR-1):1-20. PMID: 22237112. Pediatrics.

Patient-Centered 52

Patient-Centered Patients IT Hospital 52

GeriPal

FEBRUARY 2, 2024

First, in our editorial, we expressed concern about the length of stay metric not being patient centric, though important for health systems focused on cost savings. And, of course, this is what families of patients undergoing palliative care go through. This is 24,000 encounters, over 15,000 patients, 11 hospitals, eight states.

Consulting 120

Consulting Hospital Patient-Centered IT 120

GeriPal

APRIL 6, 2023

A friend of GeriPal, and prior guest, Guy Micco commented today that we need an RCT for chaplaincy is like the idea that the humanities need to justify their value in medical training: “It’s like being told to measure the taste of orange juice with a ruler.” I don’t see a lot of those out there. Is that your grandchildren?

IT 99

IT Patient-Centered Families Family 99

GeriPal

DECEMBER 7, 2023

Elders Climate Action, and let me just tell you a little bit about who we are, was created in 2014 as the project of a 501(c)(3), Elders Action Network. What do we do to very concretely provide heat shelters and cool shelters? I mean, many people in their mid to older years are on certain medications. Ruth: Right. Ruth: Yeah.

Healthcare 129

Healthcare IT Education Community 129

BMJ

AUGUST 20, 2021

doi: 10.1136/fmch-2021-001143 The COVID-19 pandemic has resulted in profound changes in patient and prescriber behaviour. Increased health anxiety has been a feature of the pandemic, with fears around leaving the home, social distancing, hand hygiene, and shortages of goods and medications due to panic buying commonplace.

Primary Care 40

Primary Care Supply Chain General Practitioner Vaccination 40

Physician's Weekly

JUNE 17, 2025

But that’s when his family began fighting another adversary: their health insurer, which decided the treatment was “not medically necessary,” according to insurance paperwork. Insurers have used prior authorization for decades to limit fraud, prevent patient harm, and control costs. . The practice isn’t new.

Insurance 52

Insurance Patients Behavioral Health Services Diagnose 52

PEMBlog

MAY 9, 2024

Nat Genet 2014; 46:1274. Both the motor movements and characteristics of the seizure, as well as the duration, are really hard to assess in a patient’s home. Obviously, you should ask about immunization status and whether or not the child has any underlying medical or neurologic problems or developmental delay.

Illness 59

Illness Vaccination Families Family 59