Referred to the House Committee on Education and Workforce.

Original title: “HR 9081: Healthcare Freedom and Fairness Act”

Referred to the House Committee on Education and Workforce.

Original title: “HR 9045: Early Childhood Mental Health Support Act”

Referred to the House Committee on Education and Workforce.

Original title: “HR 8978: Enhancing Mental Health and Suicide Prevention Through Campus Planning Act”

Draft guidance outlines a “plausible mechanism” pathway to support approval of highly targeted therapies when traditional trials are not feasible. It is designed to help sponsors generate substantial evidence of effectiveness and safety using a combination of clinical, nonclinical, and manufacturing data tailored to highly specific therapies.2 · “President Trump promised to accelerate cures for American families—and we are delivering, especially for children with ultra-rare diseases who cannot afford to wait,” said Health and Human Services Secretary Robert F. At its core, the approach emphasizes several foundational elements: identifying the disease-causing mechanism, demonstrating that the therapy directly targets that mechanism, and confirming successful biological engagement. Sponsors are also expected to rely on well-characterized natural history data and show improvements in clinical outcomes or validated biomarkers. “This guidance is a critical step the FDA is taking to tailor our regulatory approach to patients with ultra-rare conditions,” said FDA Commissioner Marty Makary, MD, MPH. https://www.fda.gov/news-events/press-announcements/fda-launches-framework-accelerating-development-individualized-therapies-ultra-rare-diseases · 2. Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause: Draft Guidance for Industry. FDA. Accessed March 2, 2026. ... 3. FDA Removes Two Study Requirement for New Drug Approval Process. Applied Clinical Trials. Makary and Prasad argued that advances in biology and trial design justify the change, writing, “In this setting, over-reliance on two trials no longer makes sense.” · The policy is expected to streamline development while placing greater emphasis on study quality, biological plausibility, and overall strength of evidence. 1. FDA Launches Framework for Accelerating Development of Individualized Therapies for Ultra-Rare Diseases.

Original title: “FDA Introduces New Framework to Advance Individualized Therapies for Ultra-Rare Diseases | Applied Clinical Trials Online”

Referred to the House Committee on the Judiciary.

Original title: “HR 5985: Expanding Health Care Providers for Veterans Act”

The Supreme Court ruled that a knockoff version of Amarin’s Vascepa didn’t infringe on patents — a decision with far-reaching implications for the availability of generics.

Original title: “Generic drugmakers gain key victory in ‘skinny label’ patent case”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 8970: Gambling Disorder Health Study Act”

The FDA hasn’t been transparent and open enough with how it has implemented the Commissioner’s National Priority Voucher program, patient, industry and trade groups said Thursday.

Original title: “Stakeholders want Makary’s voucher program paused, calls for FDA independence”

Referred to the House Committee on Energy and Commerce.

Original title: “HRES 1245: Recognizing the importance of the Greenhouse Gas Reporting Program to protect the United States' scientific integrity, public health, environment, and economic growth.”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 8829: Reproductive Health Care Accessibility Act”

The Food and Drug Administration (FDA) is classifying the absorbable metallic bone fixation fastener into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the absorbable metallic bone fixation fastener. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device.

Original title: “Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener”

The Food and Drug Administration (FDA) is announcing the availability of the guidance "Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements." This guidance describes FDA's intent to exempt certain unclassified medical devices from premarket notification requirements. At this time, and based on the information currently available to the Agency, FDA believes the devices identified in this guidance meet the standards for exemption from premarket notificatio

Original title: “Intent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability”

The Food and Drug Administration (FDA) is classifying the shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis. We are taking this action because we have determined that c

Original title: “Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Uncemented Prosthesis”

The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial into class II (special controls). The special controls that apply to the product type are identified in this order and will be part of the codified language for classification of the resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial. We are taking this action because we have determined that cl

Original title: “Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycoside Antibacterial”

Original title: “National Library of Medicine; Notice of Partially Closed Meeting”

Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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 4849: Protecting Health Care and Lowering Costs Act of 2025”

Motion to reconsider laid on the table Agreed to without objection.

Original title: “HRES 1333: Providing for consideration of the bill (H.R. 8646) making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2027, and for other purposes; providing for consideration of the bill (H.R. 7726) to amend the Child Care and Development Block Grant Act of 1990 to withhold funds from noncompliant States under such Act; providing for consideration of the bill (H.R. 7892) to amend the Higher Education Act of 1965 to require to the Secretary of Education to use an identity fraud detection system to review each FAFSA to determine whether the FAFSA presents a reasonable suspicion of identity fraud; and providing for consideration of the bill (H.R. 8872) to amend part A of title IV of the Social Security Act to target funds to low-income families, strengthen program integrity guardrails for State expenditure of funds, require measurement of improper payments, and establish goals for eliminating fraud and improper payments under the program of block grants to States for temporary assistance for needy families, and for other purposes.”

This document sets forth these final rules related to certain provisions of the No Surprises Act regarding the Federal independent dispute resolution (IDR) process, which was established as part of the Consolidated Appropriations Act, 2021 (CAA). These rules finalize new requirements relating to the disclosure of information that group health plans and health insurance issuers offering group or individual health insurance coverage must include along with the initial payment or notice of denial o

Original title: “Federal Independent Dispute Resolution Operations”