FDA Law

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

Clinic 64

Clinic Relationship Provider IT 64

FDA Law

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). By Steven J.

Clinic 59

Clinic Management Medical IT 59

FDA Law

OCTOBER 7, 2024

2117 (2024). FDA has civil money penalty authority relating to clinical trials, devices, foods, drugs, and tobacco; although with the exception of tobacco, FDA has not recently exercised that authority with regularity. Constitution’s Seventh Amendment right to a jury trial. See SEC v Jarkesy , 144 S. In Huff and Puffers v. filed Sept.

Electronics 59

Electronics IT Government Provider 59

FDA Law

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law

JUNE 27, 2024

50,372 , 50,377 (June 13, 2024). Public Interest Factors The Controlled Substances Act provides that DEA may suspend or revoke a registration upon finding that the registrant has committed acts that would render the registration inconsistent with the public interest. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 21 U.S.C. §

Insurance 52

Insurance Patients Utilities Chronic Condition 52

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

In 2024, 75% of infectious disease physicians who chose an assessment opted for the LKA over the traditional, 10-year MOC exam. Some members of the Specialty Board were interested in the LKA experience, participant survey results—particularly responses about fairness—and how LKA performance data might reflect on clinical outcomes.

Board-Certified 52

Board-Certified Government Community Education 52

Medical Xpress

JUNE 16, 2025

This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding. The content is provided for information purposes only. But technical limitations have made it hard to understand how neurons in this area form functional circuits."

Provider 111

Provider Complication Medical Diabetes 111

ABIM

JUNE 24, 2025

In 2024, 78% of hematologists who were due for an assessment and chose to enroll in one chose the LKA over the traditional, 10-year MOC exam, which is on par with the average across specialties. Community Practice in ABIM Governance* Erica N. Most (49.5%) are in single-specialty group practice or multi-specialty group practice (38%).

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

ABIM

MAY 30, 2025

Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. In 2024, 77% of ABIM Board Certified nephrologists due for an assessment opted for the LKA over the traditional, 10-year MOC exam. Community Practice in ABIM Governance* Erica N.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

FDA Law

MARCH 6, 2025

inpatient hospital, out-patient clinic), date range for the data, and location of the data collection sites (e.g., The DCP should follow applicable regulations governing human subject protections, where applicable. OUS data may introduce bias if the OUS population does not reflect the U.S. data acquisition device).

Manufacturing 105

Manufacturing Management Clinical Practice Clinic 105

FDA Law

MARCH 15, 2023

See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006). Current regulations do not require breast density notification to be part of the healthcare provider report or the lay summary to the patient.

Healthcare 59

Healthcare Diagnosis Provider Individual 59

FDA Law

APRIL 8, 2024

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017. Section I.C

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

GeriPal

JANUARY 11, 2024

A planned expansion of MAID to include people with mental illness was placed on hold until March 2024. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. ABIM MOC credit will be offered to subscribers in November, 2024.

Illness 144

Illness IT Medical Provider 144

Medical Xpress

JUNE 7, 2025

The company is working with governments and health groups in the U.K. The content is provided for information purposes only. In clinical trials, no participants who received the injection acquired HIV. But Gilead says the shot should help expand the overall number of people using PrEP in both the U.S. and abroad.

Vaccination 71

Vaccination Insurance Medical Diabetes 71

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.”

Patient-Centered 125

Patient-Centered IT Families Family 125

FDA Law

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

Physician's Weekly

JULY 2, 2025

Maria is among what the federal government estimates are 2.6 without legal permission — along with the providers and community workers that help them — are anxiously weighing the benefits of pushing forward with Medi-Cal applications against the risks of discovery and deportation by the federal government. Currently, about 1.6

Community 52

Community Government Insurance Provider 52

Physicians News Digest

APRIL 17, 2025

including in most states that backed President Donald Trump in the 2024 election. Those changes — plus the firing of 1,200 agency employees as part of mass layoffs across the government — are alarming scientists and NIH workers, who warn that they will undermine progress in combating diseases and other threats to the nation’s public health.

Vaccination 52

Vaccination Government Patient-Centered Hospital 52