FDA Law

APRIL 14, 2022

The draft MDUFA V commitment letter starts with a 70% goal in FY 2023, but if the de novo decision goal is met in FY 2023 and the fee revenue amount provided for FY 2026 and 2027 is adequate to support performance improvements, FDA plans to increase the goal to 80% in FY 2026.

Provider 40

Provider Clinic Medical IT 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*.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 11, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. ABIM’s website features expansive sections on research related to assessment and clinical outcomes.

Board-Certified 52

Board-Certified Government Community Education 52

ABIM

JUNE 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. 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

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Of note, the findings so far indicate that 90% of nephrologists who responded are clinically active. ABIM will begin accepting applications for that opening and others later this year.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

FDA Law

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R. 820.198). .

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

GeriPal

APRIL 3, 2025

I will always, as always, say, you know, you’re welcome to do this in 2026. That was actually Ken, you remember that article, Nancy Schoenberg’s article on screening and what to say and what not to say to patients on how to talk. How to talk to patients about screening colonoscopies. Of course. We will step aside.

IT 64

IT Hospital Screening Patients 64

FDA Law

JUNE 14, 2023

The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach market, whether due to reimbursement and/or physician or patient preference. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).

Manufacturing 45

Manufacturing Medical Patient-Centered Appointment 45

Physician's Weekly

JUNE 26, 2025

His clinical study was ending. He directed the patients to seek local help. While it’s possible that Nath’s patients suffered covid vaccine injuries, Marks said, their symptoms were so varied it was hard to characterize a possible syndrome. .” But, Dressen said, there wasn’t any. Kennedy Jr.

Vaccination 52

Vaccination Patient-Centered Government IT 52

FDA Law

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. Department of Justice counsel strongly defended the rule throughout the hearing.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

Physician's Weekly

JUNE 26, 2025

Gavin Newsom has asked lawmakers to push the implementation date to January 2026, leaving patients, insurers, and employers in limbo. During IVF, a patient’s eggs are retrieved, combined with sperm in a lab, and then transferred to a person’s uterus. A single cycle can total around $25,000 , out of reach for many.

Insurance 52

Insurance Patient-Centered Provider Management 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.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98