speed over value korea s recent overhaul in pharmaceutical pricing and reimbursement

Original title: “Speed over Value: Korea's Recent Overhaul in Pharmaceutical Pricing and Reimbursement.”

The FDA must strengthen its capacity and create clearer pathways so that rare-disease patients can access lifesaving treatments sooner. Through my work with rare disease patients and families, I have seen firsthand the toll of delayed diagnoses, limited treatment options, and uncertainty. For these patients, the question is not only how quickly the FDA reviews a drug, but whether its system can evaluate therapies with patients’ realities in mind. For decades, single-arm trials — those without a randomized control group — were a standard route to approval for rare, rapidly progressing diseases. When no FDA-approved alternative exists, assigning patients to a placebo or an inferior treatment may be impractical or unethical. That approach was questioned last year after comments attributed to the FDA’s Center for Biologics Evaluation and Research raised doubts about whether single-arm data would still meet the bar for rare-disease approvals. FDA leadership has since backtracked, saying the comments do not reflect official policy. Developers still lack clarity as they design trials. Rare-disease treatments may need different routes to the same evidentiary standard. Trial delays, enrollment challenges, or prolonged reviews can mean months or years of uncertainty for people whose diseases are progressing. They may not live to see a lifesaving solution reach the market. I VOTED FOR TRUMP AND RFK JR. TO CLEAN UP OUR FOOD. THIS FDA NOMINEE THREATENS THAT PROMISE ... Patient stories cannot replace clinical evidence, but they can help regulators understand its consequences and context.

Original title: “The FDA’s new leadership must give rare disease patients a clearer path”

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be "delisted" by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily reli

Original title: “Patient Safety Organizations: Delisting for Cause for the Hospital Rep Safety Solutions Corp. PSO”

The Administration for Children and Families (ACF) is requesting a 3-year extension of the U.S. Repatriation Program forms (OMB #0970-0474, expiration 1/31/2027). There are several changes requested to the thirteen forms. Burden estimates have also been updated.

Original title: “Proposed Information Collection Activity; U.S. Repatriation Forms”

Patients had adverse events after receiving a Fresenius Kabi medicine that experienced manufacturing deviations.

Original title: “Fresenius Kabi manufacturing plant hit with FDA warning letter after adverse events”

EMA has endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) calling on medicine developers, manufacturers, regulators and…

Original title: “Global regulators call for advancing alternatives to animal testing across the medicine lifecycle”

In this episode of Denatured, you’ll hear from Max Bronstein, CEO of Aviva Strategies and Teresa Barnes, Chief Executive Warrior of PF Warriors. We dig into why U.S. patients are losing access to rare disease trials happening abroad and how the FAIR Act’s accelerated, harmonized reviews could help the U.S. keep pace while getting lifesaving studies to patients faster.

Original title: “The race for access: How the FAIR Act could reclaim U.S. biotech leadership”

Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 10707: To address barriers immigrants and refugees face to entering the health care workforce, and for other purposes.”

The Office of Refugee Resettlement (ORR) published a notice in the Federal Register of July 14, 2026, extending the eligibility time period for Refugee Cash Assistance (RCA) and Refugee Medical Assistance (RMA). After further review of the considerations listed 45 CFR 400.211, ORR determined that the eligibility period should be 12 months. This submission is to correct the time eligibility period to 12 months for both programs.

Original title: “Period for Refugee Cash Assistance and Refugee Medical Assistance; Correction”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 10708: To authorize the Secretary of Health and Human Services to award grants to reduce barriers to immigrants becoming nurses or allied health professionals in the United States, and for other purposes.”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 10649: To amend the Comprehensive Addiction and Recovery Act of 2016 to authorize the Attorney General, in coordination with the Administrator of the Drug Enforcement Administration, the Secretary of Health and Human Services, and the Director of the Office of National Drug Control Policy, to award grants to covered entities to establish or maintain disposal sites for unwanted prescription medications, and for other purposes.”

Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 10640: To amend title XI of the Social Security Act to establish an Urban Health Transformation Program.”

This document corrects technical errors in the final rule that appeared in the August 3, 2026 Federal Register titled "Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program".

Original title: “Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program; Correction”

This document corrects technical errors in the final action that appeared in the July 31, 2026 Federal Register titled "Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System--Rate Update".

Original title: “Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update; Correction”