ABIM

JUNE 12, 2025

Upgrades to the ABIM website and Physician Portal for 2025, designed to make it easier for both physicians and the public to find information. Community Practice in ABIM Governance* Erica N. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations.

Board-Certified 52

Board-Certified Internal Medicine Government Community 52

FDA Law

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Clinic 64

Clinic Clinical Practice Provider Utilities 64

Annals of Family Medicine

NOVEMBER 20, 2024

HTA organizations are generally funded by governments, they guide health care professionals and decision/policy-makers, and they publish knowledge translation products such as guidelines. learning), the use of guideline-based information in clinical practice, and subsequent patient health outcomes. Health organization outcomes.

General Practitioner 130

General Practitioner Lab Testing Relationship Family Physician 130

FDA Law

OCTOBER 1, 2024

District Court for the District of Columbia (“DDC”) against FDA alleging that the Agency’s structure of NDA review is unconstitutional (by our count the 31st Vanda litigation against FDA or another government entity in the last five years, including appeals). In January 2024, the U.S. VANDA PHARMACEUTICALS, INC. VANDA PHARMACEUTICALS, INC.

Government 59

Government Appointment IT Manufacturing 59

BMJ

AUGUST 20, 2021

Donors, government ministries, agencies and academic partners regularly cascade requests for data that multiply and complicate the simple interaction into a complex, and often redundant, set of data requirements for the same singular interaction. Mobile phone penetration has finally exceeded 90% in low- and middle-income countries.

Patient-Centered 40

Patient-Centered Provider Clinic Patients 40

Permanente Medicine

APRIL 16, 2025

Both groups have a shared mission of delivering high-quality, cost-efficient care that achieves superior clinical outcomes. By collaborating clinically, sharing innovations, and supporting physicians and staff, NWP will improve quality of care. We are dedicated to the mission of improving the health of our patients and communities.

Medical 52

Medical Patient-Centered Community Hospital 52

ABIM

APRIL 24, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. Community Practice in ABIM Governance* Dr. Johnson led a discussion with the Rheumatology Board on community practice in rheumatology to create a more inclusive understanding of its role and scope.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

PEMBlog

JUNE 7, 2023

Government. For more information, please visit HRSA.gov To learn more about the Emergency Medical Services for Children Innovation and Improvement Center visit [link] Email km@emscimprovement.center Follow on Twitter @EMSCImprovement References Kupas D et al.

Transportation 122

Transportation Patient-Centered Management Finance 122

FDA Law

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.

Manufacturing 105

Manufacturing Clinic IT Utilities 105

FDA Law

MARCH 3, 2024

This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act? House of Representatives ( H.B.

Manufacturing 102

Manufacturing Government Consulting IT 102

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. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

JULY 24, 2023

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

Clinic 52

Clinic Provider IT Patients 52

FDA Law

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. By Steven J.

IT 64

IT Manufacturing Government Clinic 64

FDA Law

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. Youth behavioral data was not specifically required but FDA encouraged such information. But they did not submit information specific to flavored products.

Manufacturing 115

Manufacturing IT Provider ER 115

Permanente Medicine

MAY 20, 2025

Contributing to this challenge is the exponential growth of information, an expanding population of older adults, and office visit documentation. Information is coming at clinicians, whether they be doctors, nurses, pharmacists, faster than ever, and there is a transparency that exists around us.

Patient-Centered 52

Patient-Centered Patients IT Medical 52

PEMBlog

JUNE 14, 2023

Government. For more information, please visit HRSA.gov To learn more about the Emergency Medical Services for Children Innovation and Improvement Center visit [link] Email km@emscimprovement.center Follow on Twitter @EMSCImprovement References Fiona B. PMID: 32393605. American Journal of Emergency Medicine. Doi.org/10.1016/j.ajem.2020.11.021

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Mental Health Management Patient-Centered Illness 98

FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. FDA-2021-N-1272) to inform future policy development. products intended for medical purposes).

Medical 98

Medical Manufacturing Healthcare Government 98

33 Charts

OCTOBER 2, 2021

Medicine is facing a crisis of information. Beyond the increase of biomedical information are rising demands for physician response to portal messaging (MyChart messages) and review of wearable generated data. And in my experience the exchange of information from the Cures Act Final Rule has added new dialog around test results.

Patients 75

Patients IT Provider Family Doctor 75

FDA Law

JANUARY 12, 2025

Background on Accelerated Approval The key concept, an ingenuity of FDA itself that has been around since the beginning of accelerated approval, is to allow earlier access to a promising therapy for a serious condition with an unmet medical need based on an endpoint that is reasonably likely to predict clinical benefit.

Clinic 64

Clinic Relationship Provider IT 64

FDA Law

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). 42 U.S.C. §

Clinic 64

Clinic IT Utilities Government 64

FDA Law

SEPTEMBER 6, 2022

As the new Federal Register notice explains, FDA issued the 2016 Guidance in question and answer format to respond to the most frequently asked questions about charging for investigational drugs provided under an IND for either clinical trials or expanded access for treatment use under 21 CFR section 312.8. Changes from the 2016 Guidance.

Clinic 52

Clinic Manufacturing Patients IT 52

The Clinical Problem Solvers

NOVEMBER 22, 2021

Dr. Neuner reminds us of the importance of centering Indigenous Peoples in our research and data because this information helps drive policy and health initiatives that can address barriers to health in the community. The Clinical Problem Solvers Podcast. Do not exclude Indigenous peoples in your research narratives. November 23, 2021.

Community 52

Community Patient-Centered Medical Student Medical 52

FDA Law

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. FDA-2021-N-1272) to inform future policy development. products intended for medical purposes).

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law

MARCH 1, 2023

The purpose of these two pilot programs was initially to inform development of a FDA rating system to characterize the QMM of a facility. On November 2, 2022, the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee held a meeting on CDER’s QMM Program. A brief discussion on the scoring approach is provided below.

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

Manufacturing 52

Manufacturing Government Referral Provider 52

FDA Law

JUNE 16, 2023

Under Minnesota’s Prescription Drug Price Transparency Act , manufacturers must submit detailed pricing information for any generic prescription drug with a WAC of at least $100 for a 30-day supply or shorter course of treatment for which it increased the WAC by 50% or greater over the previous 12-month period.

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law

OCTOBER 25, 2021

Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R. The regulatory uncertainty has ill?befitted

Manufacturing 52

Manufacturing Specialization Government IT 52

FDA Law

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. In short, Voluntary Consensus Standards (VCS) are intended to be exactly what the name conveys – standards that are adopted by consensus and are not mandatory (not legal or regulatory requirements).

Provider 59

Provider Screening IT Government 59

FDA Law

JANUARY 6, 2022

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(b)(2). Graves , 2021 U.S. LEXIS 29248, at *2-3 (D.

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

GeriPal

JULY 19, 2024

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. What hasn’t been shown, Eric, is that if you apply tools like this, clinical outcomes down the road are better for patients.

Screening 119

Screening Primary Care Patient-Centered IT 119

FDA Law

JUNE 27, 2024

The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. The regulation requires that pharmacists “ensure that a reasonable effort is made to obtain” this information. 21 U.S.C. § 823(g)(1)(B), (D). at 50,376. “A 21 C.F.R. §§ 1306.04(a), a), 1306.06. Code § 64B16-27.810(1).

Insurance 52

Insurance Patients Utilities Chronic Condition 52

FDA Law

JANUARY 6, 2022

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 220(b)(2). Graves , 2021 U.S. LEXIS 29248, at *2-3 (D.

Lab Testing 40

Lab Testing Referral Individual Patient-Centered 40

ABIM

JUNE 4, 2025

Representatives from the American Association of Clinical Endocrinology (AACE), the Association of Program Directors in Endocrinology, Diabetes and Metabolism (APDEM) and the Endocrine Society joined for a portion of the meeting*. Community Practice in ABIM Governance* Erica N.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 11, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. ABIM’s website features expansive sections on research related to assessment and clinical outcomes. Community Practice in ABIM Governance* Erica N.

Board-Certified 52

Board-Certified Government Community Education 52

ABIM

JUNE 24, 2025

Upgrades to the ABIM website and Physician Portal for 2025, designed to make it easier for both physicians and the public to find information. Preliminary data show that 90% of respondents are clinically active with the majority in hospital- or system-owned practice (38%), academic faculty practice (32.9%) and private practice (26.8%).

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

ABIM

MAY 30, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier to find information for both physicians and the public. Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. Community Practice in ABIM Governance* Erica N.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

Tiny Physician

DECEMBER 11, 2021

The PG doctors strike has entered its 12th day at the time of publishing this article and it has badly affected the patient care at the Government Medical Colleges (GMCs). KMPGA put forward the following demands in front of the state government: 1. How did the Kerala Government react to these demands?

Patients 52

Patients Government Appointment Finance 52