FDA Law Blog

DECEMBER 11, 2023

During the October 31, 2023 webinar discussing the proposed rule, stakeholders sought clarity from FDA officials on the Agency’s plan to address the resource gap. Fourth, the inability to manage this influx will harm the diagnostic industry, including manufacturers of distributed IVD products. 31, 2023), [link]. [10] 11] Jeffrey N.

IT 69

IT Medical Patient-Centered Provider 69

FDA Law Blog

OCTOBER 10, 2023

Non-Clinical Recommendations The draft guidance highlights non-clinical review areas that are generally relevant across 510(k) Implants and offers recommendations for performance data to include in a 510(k) submission. We find that this information is noteworthy for manufacturers to consider.

Manufacturing 45

Manufacturing Engineering Clinic Patients 45

FDA Law Blog

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. based upon the anticipated clinical benefit of earlier patient access to the product.”.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Today's Hospitalist

JUNE 7, 2025

Key takeaways: Hospitalists will increasingly have to manage inpatients taking GLP-1s. They presented a rapid clinical update Webinar in May 2025 hosted by the Society of Hospital Medicine. ” That is why, she added, anti-obesity medications are such an important strategy in long-term management.

Hospital 66

Hospital Management Diabetes Patients 66

FDA Law Blog

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). User Interface Software Description Section VI.B test data should not be cleaned).

Management 95

Management Provider Specialization Clinic 95

GeriPal

NOVEMBER 17, 2022

And when I was getting my PhD, I wanted to find something that spoke to me, and I had been doing clinical work in nursing homes. ” And the requests from management were to ask her to prescribe antipsychotics to try and sedate some of these behaviors away. I barely know what it is.”

Community 97

Community IT Mental Health Medical 97

GeriPal

SEPTEMBER 14, 2023

That’s focused on older adults who are too frail to get into clinic. In that clinical experience, we saw a lot of older adults who would develop acute illness, often exacerbations of their chronic conditions. We relied on our clinical experience as geriatricians, that home-based primary care experience. Bruce: Sure.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115