FDA Law

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance. Other medical information.

Clinic 52

Clinic Medical Provider Patients 52

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. I’m guessing not. How to screen for hearing loss. Transcript.

IT 102

IT Screening Hospital Clinic 102

FDA Law

OCTOBER 16, 2024

To that end, FDA approved the MSN ANDA without the modified dosing regimen and with the indication “to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction.

Manufacturing 98

Manufacturing Patients IT Hospital 98

FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. HHS would then use MRAP scores in the proposed Hospital Resilient Supply Program (HRSP).

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

FDA Law

OCTOBER 17, 2023

This implies that if device technologies and features can produce a clinically meaningful impact for the treatment or diagnosis of a condition in certain populations, such data could support the case that the device satisfies the first designation criterion.

Medical 53

Medical Diagnosis Healthcare Clinic 53

GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. Alex 00:33 Our next guest is Margaret Ross, who’s a clinical psychologist and researcher at St. Vincent’s Hospital in Melbourne, Australia.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

MARCH 2, 2023

Eric: And we have Tasce Bongiovanni, who is an acute care trauma surgeon at UCSF and the San Francisco General Hospital. I also heard that if you look at all individuals in the US, about 4% of individuals are taking one of the gabapentinoids, 10% over 65. Welcome to the GeriPal podcast, Nisha. Nisha: Thank you so much.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

MARCH 24, 2022

Although, certainly when you start facing complications of serious illness, it is increasingly important to engage as individuals and conversations about goals, values, and preferences. So every transition into the hospital, every transition out of the hospital. I think Bob also noted documenting it.

Illness 72

Illness IT Healthcare Patient-Centered 72

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

There have been a few severe cases and one individual died with H5N1 infection. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. The Bureau of Clinical Laboratories at ADPH is also providing testing but should be prioritized for patients that are underinsured or uninsured.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. And so we do see hospital admissions for heat exposure and certainly cardiovascular and respiratory problems related to air pollution with climate change and also cognitive problems.

Healthcare 129

Healthcare IT Education Community 129

FDA Law

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98