CDOCS

FEBRUARY 14, 2025

png]</p> <h3><span style="font-size:14px"><strong>Bulk Download of Patient Files</strong></span></h3> <p><span style="font-size:12px">Managing& patient data is now easier with bulk download functionality.

Management 52

Management Manufacturing Patients Specialization 52

The Medical Futurist

JUNE 21, 2025

Although this revolution has been brewing for years, the past few months marked a major change , as algorithms finally moved out of the specialized labs and into our daily lives. The situation today is as follows: One company manufactures software for the radiology department which use a certain format of AI in their daily work.

Healthcare 53

Healthcare Healthcare Professional Electronics Medical 53

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

MARCH 9, 2025

As such, we can offer our readers a special 10% discount. John Claud will speak at a session titled Beauty in Developing World Markets: Contrasting Opportunities and Challenges in the Latin American and Chinese Cosmetics Markets, where he will explore two areas of global focus for the cosmetics industry: Latin America and China.

Manufacturing 59

Manufacturing Specialization Provider Management 59

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.

Manufacturing 59

Manufacturing Management Utilities Relationship 59

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. Despite the limitations in testing, some of the findings were noteworthy. Key Performance Indicators.

Manufacturing 72

Manufacturing Specialization Management IT 72

FDA Law Blog

MARCH 6, 2024

Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity.

Management 59

Management Manufacturing Government Specialization 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. The policies and procedures should include a section on how the registrant handles DEA inspections.

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. The policies and procedures should include a section on how the registrant handles DEA inspections.

Management 40

Management Consulting Provider Physicals 40

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

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. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.

Manufacturing 64

Manufacturing Engineering Medical IT 64

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that test articles represent the worst-case manufacturing process, and provide the examples that the device undergoes the greatest number of sterilization and/or reprocessing cycles.

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. Claire: All of that, but the celebrity factor isn’t really what makes Cost Plus different: The company buys meds direct from manufacturers, and adds 15 percent to their wholesale cost. Dan: Yeah, fair.

Insurance 52

Insurance IT Board-Certified Medical 52

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

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. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? James 01:34 Yeah, right on.

Illness 109

Illness IT Patient-Centered Patients 109

GeriPal

DECEMBER 7, 2023

I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. And so if you’re talking about healthcare providers and healthcare systems, start with waste and do an education with people of how to manage the waste. And you start small.

Healthcare 130

Healthcare IT Education Community 130