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Conditions – Drugs and Biologics ,” (the Expedited Programs Guidance) This guidance noted that a “[d]esignation may be rescinded if it no longer meets the qualifying criteria for breakthrough therapy.”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 Rescinded .

IT 52

IT Clinic Provider Medical 52

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

Patients 52

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

Patients 59

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. The investigators select the drugs they will audit.

Management 40

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. The investigators select the drugs they will audit.

Management 40

Management Consulting Provider Physicals 40

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. Listening to individual stories within the context of their structural stories is important.

Community 52

Community Education Patient-Centered Relationship 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.

ER 52

ER Telehealth Primary Care Doctor Appointment 52

GeriPal

JULY 21, 2022

That’s where it really gets to this individual risks and balances, individual situation. So that’s a piece that I think is important for providers anywhere along that process to be asking about driving. And the primary care provider had assumed he was no longer driving, I think. Alex: Yeah.

IT 102

IT Family Families Diagnosis 102

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.:

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. We talk a lot about people being unhoused, which I think takes the blame away from the individual and kind of de. those experiencing homelessness). We just hired a nurse. Health and health justice.

Healthcare 100

Healthcare IT Community Illness 100

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 Family Families 59

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. Although I saw that hospice was providing a lot of really great quality care for these patients, I also saw a lot of problems.

Family 106

Family Families IT Patients 106

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. We weren’t randomizing providers or patients. Eric 26:01 Curtis’s, he had a 2014 JAMA article on simulation. This is not why I went into emergency medicine.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

GeriPal

APRIL 6, 2023

To provide context, we are joined by Karen Steinhauser, a social scientist at Duke who has been studying spirituality for years (and published one of the most cited papers in palliative care on factors considered important at the end of life , as well as one of my favorite qualitative papers to give to research trainees ). Lexy: Yeah.

IT 99

IT Patient-Centered Family Families 99

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. The catch is, as we have learned from the GSK v. Teva decision changed everything.

IT 52

IT Provider ER Insurance 52

GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. 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. Leslie: Well, yes, thank you, Ruth.

Healthcare 129

Healthcare IT Education Community 129

BMJ

JUNE 25, 2021

With landmark analysis, survival can be visualised by plotting the Kaplan-Meier survival curves for the risk groups of interest to provide information about the absolute and relative risks, whereas this is not straightforward for time-dependent Cox regression. 16 Figure 1. www.statisticsauthority.gov.uk/assessment/code-of-practice

Primary Care 40

Primary Care Clinical Practice Electronics Clinic 40

BMJ

AUGUST 20, 2021

In the United Kingdom (UK), primary care practitioners are the first-line clinicians which most patients encounter, providing initial assessment and treatment of a wide variety of conditions. Over one billion prescriptions per year are signed in the UK by these general practitioners (GPs) in primary care.

Primary Care 40

Primary Care Supply Chain General Practitioner Vaccination 40

FDA Law Blog

MAY 26, 2025

Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care. Department of Health & Human Services purporting to provide a comprehensive review of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria.

Manufacturing 59

Manufacturing Provider Medical IT 59