The Department of Health and Human Services (HHS or the Department) is notifying the public that there will be no Civil Monetary Penalty (CMP) inflation adjustment for 2026 in accordance with the April 17, 2026, guidance from the Office of Management and Budget (OMB). HHS will continue to use the 2025 civil monetary penalty levels because there will be no cost-of-living adjustment for 2026.

Original title: “No Adjustment to HHS Civil Monetary Penalty Amounts for 2026”

A new analysis from the non-profit group found that net launch prices for new medicines spiked significantly between 2022 and 2025, and the majority were well above its cost-effectiveness guidelines.

Original title: “Most new drugs are still too costly at launch, ICER says”

The U.S. Food and Drug Administration today released final guidance establishing a clear framework for how drug companies can develop, distribute, and label apps used alongside their prescription medicines.

Original title: “FDA Issues Final Guidance on Prescription Drug Apps and Software”

LSDSS highlighted that 164 patients ... ultra-rare LSDs, including Gaucher, Pompe disease. For many of these patients, treatment is not a one-time intervention. It is a continuum of care, the letter said, adding that the enzyme replacement therapy (ERT), where clinically indicated, ... LSDSS highlighted that 164 patients had exhausted the ₹50 lakh assistance under NPRD, 2021, of whom around 115 were patients suffering from ultra-rare LSDs, including Gaucher, Pompe disease. For many of these patients, treatment is not a one-time intervention. It is a continuum of care, the letter said, adding that the enzyme replacement therapy (ERT), where clinically indicated, has to be administered regularly to maintain the gains achieved through treatment and prevent further disease progression. LSDSS urges India to establish interim funding to continue life-saving treatments for rare-disease patients exhausted by NPRD's ₹50 lakh cap. Founded in 2010, the LSDSS is a non-profit organisation that works for the welfare of patients with LSDs and rare diseases in India. In a letter to Prime Minister Narendra Modi and Health Minister J P Nadda, LSDSS wrote, "We seek one immediate humanitarian measure: that all clinically eligible patients whose treatment has stopped solely because they have exhausted the ₹50 lakh financial assistance under the National Policy for Rare Diseases (NPRD), 2021, be provided an interim arrangement for continuation/ reinstatement of their life-saving treatment until the matter pending before the Supreme Court is finally resolved." The Lysosomal Storage Disorders Support Society (LSDSS) has urged the government to establish an interim funding arrangement for patients who have exhausted the ₹50 lakh National Policy for Rare Diseases (NPRD) cap, ensuring the continuation of their life-saving treatments.

Original title: “Rare disease patients urge govt for interim funding arrangement to ensure continuation of treatment - The HinduBusinessLine”

Read twice and referred to the Committee on the Judiciary.

Original title: “S 309: Smarter Pretrial Detention for Drug Charges Act of 2021”

This proposed rule would implement section 6219 (Adjustments to Medicare Part D Cost-Sharing Reductions for Low-Income Individuals), section 6220 (Requiring Enhanced and Accurate Lists of (REAL) Health Providers Act), and section 6224 (Modernizing and Ensuring Pharmacy Benefit Manager Accountability) of the Consolidated Appropriations Act, 2026.

Original title: “Medicare Program; Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026”

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry." The guidance focuses on frequently asked questions about the new dietary ingredient notification (NDIN) submissions. This guidance is intended to help provide recommendations to manufacturers and distributors of NDIs and dietary supplements contai

Original title: “New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry; Availability”

Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”

Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”

Original title: “National Cancer Institute; Notice of Partially Closed Meeting”

The Lysosomal Storage Disorders Support Society appeals to Prime Minister Narendra Modi for urgent funding to support patients facing treatment interruptions due to exhausted financial assistance under the National Policy for Rare Diseases. The letter emphasizes the necessity for a ... The Lysosomal Storage Disorders Support Society appeals to Prime Minister Narendra Modi for urgent funding to support patients facing treatment interruptions due to exhausted financial assistance under the National Policy for Rare Diseases. The letter emphasizes the necessity for a continuity-of-treatment mechanism to aid those suffering from life-threatening conditions, particularly children with ultra-rare diseases. It said 164 patients had exhausted the financial assistance available under NPRD, 2021, of whom around 115 were patients suffering from ultra-rare LSDs, including Gaucher and Pompe disease. ... Many of these patients are children as young as two, three, four or five years of age, it added. LSDSS appealed to urgently reinstate treatment for all clinically eligible patients and to establish an interim funding arrangement until the matter is sub judice before the Supreme Court. It added that a continuity-of-treatment mechanism must be established under NPRD to fill a structural gap in the implementation of the policy. LSDSS said, “A mechanism is urgently required so that a patient requiring lifelong or long-term therapy is not abruptly rendered ineligible merely because the prescribed financial ceiling has been reached.” · It also urged that children and patients at high clinical risk must be prioritised for treatment and that all concerned Centres of Excellence must be directed to identify and report such patients immediately. LSDSS said patients with progressive, potentially life-threatening conditions were facing treatment interruptions after exhausting their sanctioned financial assistance.

Original title: “Patients with Rare Diseases Urge Prime Minister Modi for Additional Treatment Funding, ETHealthworld”

Referred to the House Committee on Veterans' Affairs.

Original title: “HR 10840: To direct the Comptroller General of the United States to complete a study and report on retention practices with respect to non-clinical personnel at health care facilities of the Department of Veterans Affairs.”

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 10844: Mobile Stroke Units Improve Health Outcomes Act of 2026”

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing the date FDA will begin rejecting electronic submissions that fail new Electronic Common Technical Document (eCTD) Version 3.22 (v3.22) and Version 4.0 (v4.0) based validations. The new eCTD v3.2.2 validations are 2024 and 2025, which are high-severity validation errors as described in the Specifications for eCTD Validation Criteria. The new e

Original title: “Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 3.2.2 and Version 4.0”

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "Fit-for-Purpose Rare Disease Framework Initiative". Convened by the Reagan-Udall Foundation for, and in collaboration with FDA, the meeting will focus on developing a fit-for-purpose framework for the development and regulatory review of rare disease therapies. There will be an opportunity to request to provide public comments at the meeting. In addition, FDA is establishing a public docket to coll

Original title: “Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments”

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing support for Forward Compatibility for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.

Original title: “Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0”

The Office of Refugee Resettlement (ORR) is requesting a three-year extension with revisions of the Unaccompanied Refugee Minors (URM) Program ORR-3 Report and ORR-4 Report (Office of Management and Budget #0970-0034, expiration 11/30/2026). Revisions were made to reduce burden and streamline information collection.

Original title: “Submission for Office of Management and Budget Review; Unaccompanied Refugee Minors Program ORR-3 Report and ORR-4 Report”

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). This meeting is open to the public, limited only by the number of audio and web conference lines (1,000 lines are available). Time will be available for public comment (registration is required to provide oral comment; see the Oral Public Comment section below).

Original title: “Meeting of the Advisory Council for the Elimination of Tuberculosis”