Physician's Weekly

JULY 1, 2025

The conference highlighted the latest advances in diabetes research and improving patient care, with presentations focusing on treatment recommendations and advances in management technology. ” The study was funded by MannKind, the manufacturer of Afrezza. . ” The study was funded by MannKind, the manufacturer of Afrezza.

Diabetes 52

Diabetes Patient-Centered Management Individual 52

My Green Doctor

MAY 3, 2025

Organizations such as EyeSustain and My Green Doctor are educating clinicians and practice managers on ways to reduce medical waste and are promoting research on this topic. Single use has become the custom for most clinicians and managers, just as disposable products have become prevalent across the medical supply chain.

Medical 52

Medical Supply Chain Hospital Healthcare 52

FDA Law

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

FEBRUARY 13, 2025

Modifications to previously authorized PCCPs can be submitted via a Special 510(k), and eSTAR recommends that the manufacturer submit a clean copy and redline of the PCCP as an attachment. Manufacturers should develop the Modification Protocol consistent with their quality system and should follow their risk management processes.

Manufacturing 71

Manufacturing Management Specialization Provider 71

My Green Doctor

MAY 3, 2025

This financial predictability allows for better budgeting and resource allocation.​ – Reduced Operational Costs : Implementing energy-efficient technologies, such as LED lighting and automated energy management systems, can decrease energy consumption by up to 30%, leading to further cost reductions. ​ The use of medications in U.S.

Healthcare 52

Healthcare Healthcare Professional Consulting Management 52

Imperial Center Family Medicine

JUNE 2, 2025

The liver manufactures new cholesterol molecules and captures excess from circulation for excretion. Restoring a flourishing and diverse gut microbiome becomes essential through dietary improvements, lifestyle changes, targeted supplements, and stress management approaches. Thus, cholesterol absorption and blood levels commonly spike.

Family Medicine 52

Family Medicine DO Screening Specialization 52

FDA Law

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The final rule emphasizes risk management activities and risk-based decision making. Notably, Part 820 will look different.

Manufacturing 59

Manufacturing Management Medical IT 59

FDA Law

NOVEMBER 14, 2022

The facility fee applies to a single manufacturing facility. The guidance explains that a facility counts as a single facility subject to a single facility fee if it is under one management and in one geographic location and address, and is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug product.

Manufacturing 52

Manufacturing Individual Management Provider 52

FDA Law

JULY 22, 2021

Schlanger — Maine and Nevada previously enacted laws requiring drug manufacturers to report information about the pricing of their products. Both states’ new requirements will become effective in October 2021 and should be considered as manufacturers prepare for state drug price transparency reporting in 2022.

Manufacturing 52

Manufacturing Asthma Diabetes Family 52

GeriPal

JUNE 20, 2024

Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. On our last podcast about urinary incontinence the song request was, “Let it go.” This time around several suggestions were raised. Eric suggested, “Even Flow,” by Pearl Jam. I suggested even flow. That’s a good one.

IT 120

IT Patient-Centered Patients Clinic 120

FDA Law

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

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

OCTOBER 9, 2023

The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. Once an individual reaches this annual cap, the insurer is solely responsible for covering the individual’s remaining medical expenses that year.

Insurance 40

Insurance Manufacturing Patient-Centered Individual 40

FDA Law

JANUARY 5, 2025

In response to the proposed rule, approximately 200 comments were submitted to the docket, and a meeting took place among FDA, the White House Office of Management and Budget (OMB) and the Consumer Healthcare Products Association (CHPA). Further elaboration of FDAs view would be helpful.

Provider 59

Provider Healthcare Individual IT 59

FDA Law

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. requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners).

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

OCTOBER 10, 2022

Criterion 4 : Non-Device CDS software functions provide sufficient information about the basis for the recommendations to the HCP user, so that the HCP user does not rely primarily on any of the recommendations to make a clinical decision about an individual patient. Interpretation of Statutory Criteria Under the Final Guidance.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

MAY 19, 2023

Final Release Criteria Special Controls Sponsors will need to provide the final manufacturing release criterion with evidence that lots released at the extremes of the specification will still meet the claimed device performance (i.e., analytical, clinical and stability).

Specialization 40

Specialization Clinic Provider IT 40

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

To incentivize donations to these hospitals, the bill suggests creating a tax credit for individuals and entities to offset their state income tax liability. To incentivize donations to these hospitals, the bill suggests creating a tax credit for individuals and entities to offset their state income tax liability.

Insurance 130

Insurance Management Hospital Vaccination 130

GeriPal

MARCH 2, 2023

2022 Perioperative Gabapentin Use in Older AdultsRevisiting Multimodal Pain Management JAMA IM. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. J Am Geriatr Soc.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law

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

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. We begin with a refresher on psilocybinwhat it is, how it might work, what conditions it may help treat (including demoralization), and how its typically administered. It’s there.

Illness 107

Illness IT Patient-Centered Patients 107

FDA Law

FEBRUARY 22, 2022

The good news is that the NIH’s program is real and has been offering helpful assistance to manufacturers seeking to obtain Emergency Use Authorization (EUA) approval from FDA for OTC rapid antigen tests. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

Manufacturing 52

Manufacturing Screening Provider Clinic 52

FDA Law

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. By Larry K. Quoted in Id. 29, 2023). Letter to U.S. 21 U.S.C. §

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95

FDA Law

OCTOBER 17, 2023

The new guidance also presents an opportunity for device manufacturers working for patient populations affected by rare life-threatening or irreversibly debilitating diseases or conditions, such as sickle cell disease. Other Updates With respect to the first part of the first criterion (i.e., Emphasis added.)

Medical 53

Medical Diagnosis Healthcare Clinic 53

GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. 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.

Healthcare 129

Healthcare IT Education Hospital 129

FDA Law

SEPTEMBER 8, 2022

As it stands, the rule allows insurers and pharmacy benefit managers (PBMs) to broadly use copay accumulator programs, which have long been criticized by patient advocacy groups as padding insurers’ pockets while leaving patients high and dry. These prohibitions are often referred to as copay accumulator adjustment programs.

Insurance 83

Insurance Patients Manufacturing Patient-Centered 83

FDA Law

AUGUST 3, 2021

Department of Health and Human Services in December 2020 to prevent Medicare Part D and Medicaid Managed Care plans from receiving rebates from manufacturers unless the rebates are passed through to pharmacies to reduce patient out-of-pocket expenses. By Faraz Siddiqui — On Monday August 2, 2021, the Senate took up for review H.R.

Manufacturing 52

Manufacturing Transportation Government Management 52

FDA Law

SEPTEMBER 14, 2021

The most far reaching drug pricing provision of Subtitle E is an amendment to the Social Security Act to establish a Fair Price Negotiation Program applicable to Medicare Parts B and D as well as group and individual health plans in the commercial market. the amount Part D plans pay pharmacies for the drugs).

Manufacturing 52

Manufacturing Insurance Government Patients 52

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. Last Thursday, the U.S.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98