Minnesota Academy of Family Physicians

MARCH 27, 2025

Schools are seeing increased concerns related to managing acute and chronic health conditions, mental health issues and health fragility. The Minnesota Council of Health Plans (MCHP) raised concerns, as the bill enacts new regulations on health plans, and they contend they have little control over pricing set by drug manufacturers.

Family Physician 52

Family Physician Insurance Finance Individual 52

FDA Law Blog

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion. analytical, clinical and stability).

Specialization 40

Specialization Clinic Provider IT 40

FDA Law Blog

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. Granted COVID has impacted regular DEA inspection schedules for most local DEA offices, but that is likely to change in the coming months.

Management 40

Management Manufacturing Specialization IT 40

FDA Law Blog

OCTOBER 31, 2022

It seems that FDA may have validated that, even with an Excellence Appraisal above and beyond standard compliance with good manufacturing practices, there is a need for pre-market review for Class 2 devices. We have followed it over the last five years, with blog posts here , here , here , here , here , here , and here. Key Findings at 12.

Manufacturing 72

Manufacturing Specialization Management IT 72

FDA Law Blog

MAY 27, 2024

She also specializes in medical device software and digital health. Ellison, Managing Director at HPM. She also managed the cross-functional team responsible for obtaining Apple’s first de novo authorizations for the ECG app and irregular rhythm notification. Hyman, Phelps & McNamara, P.C.

Manufacturing 59

Manufacturing Management Utilities Relationship 59

FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. By Larry K.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. By Larry K.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec.

Manufacturing 64

Manufacturing Engineering Medical IT 64

FDA Law Blog

FEBRUARY 19, 2024

Loloei also served as a Senior Policy Advisor in CDRH and as a Special Advisor in the Office of the Commissioner. Loloei will focus on guiding clients through complex premarket and postmarket regulatory requirements and assisting with the management of total product life-cycle matters. While at FDA, Ms. During her FDA tenure, Ms.

Engineering 59

Engineering Manufacturing Specialization Management 59

FDA Law Blog

SEPTEMBER 26, 2022

Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). By way of background, 21 C.F.R. § 21 C.F.R. §

Manufacturing 40

Manufacturing Specialization Provider Medical 40

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. Many sponsors want to reduce animal testing and, therefore, welcome the approach. The main body of the draft guidance provides high-level recommendations, and four appendices provide detailed recommendations for test design.

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

Manufacturing 105

Manufacturing Provider IT Electronics 105

Physician's Weekly

JUNE 19, 2025

Back in February, we asked you, our listeners, to tell us how you’ve managed when your prescriptions got really expensive. In January of last year, Cole went to a Walgreens in Appleton, Wisconsin, to get refills on the medication he used to control his asthma. He’d have to pay more than 500 dollars. He left without it.

Insurance 52

Insurance IT Board-Certified Medical 52

GeriPal

MAY 8, 2025

So in our trial, because of security reasons, we are required by Health Canada to store the substance in a special secure area in my office. We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. It’s there. Alex 02:16 Jim Low e.

Illness 109

Illness IT Patient-Centered Patients 109

FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

GeriPal

DECEMBER 7, 2023

Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US. My kids ask – why don’t adults care about this issue the same way that they and their friends care about it? Ruth: Thank you.

Healthcare 130

Healthcare IT Education Community 130