U.S. President Donald Trump signed a spending package into law Tuesday that reauthorizes the FDA’s previously stalled rare pediatric disease priority review voucher program, among other initiatives, while ending a three-day partial government shutdown.

Original title: “Rare Pediatric Disease Vouchers Reauthorized, PBM Reform Funded in Narrowly Passed Spending Bill”

Patients with rare cancers will be able to register their interest to join clinical trials through the NHS App. On 31 January 2026, the government announced that it will be further integrating the ‘Be part of research’ service into the NHS App so that patients with rare cancers — including ... Patients with rare cancers will be able to register their interest to join clinical trials through the NHS App. On 31 January 2026, the government announced that it will be further integrating the ‘Be part of research’ service into the NHS App so that patients with rare cancers — including brain cancers — “will be […] “Increasing patients’ awareness and support for clinical research will help to boost numbers and importantly inclusivity and diversity of clinical trials participants in the UK.” · In November 2025, the Medicines and Healthcare products Regulatory Agency announced that it would speed up access to treatments for rare diseases, including approving therapies for small populations with limited clinical data. The Pharmaceutical Journal from the Royal Pharmaceutical Society Claire Anderson, president of the Royal Pharmaceutical Society, commented: “Using the NHS App to connect patients with rare cancers to relevant clinical trials is a positive step towards widening access to innovative treatments.

Original title: “Patients will be able to join clinical trials through NHS App - The Pharmaceutical Journal”

Today, our rare disease community has a reason to celebrate, as Congress passed legislation that includes a five-year reauthorization of the Rare Pediatric Disease Priority Review Voucher (PRV) Program, increased funding for rare disease research, and other […] The post Congress Passes Five-Year Reauthorization of Rare Pediatric Disease PRV Program appeared first on EveryLife Foundation for Rare Diseases.

Original title: “Congress Passes Five-Year Reauthorization of Rare Pediatric Disease PRV Program”

The agency’s program will be open to pharmaceutical facilities that align with “national priorities.” Elsewhere, a self-administered lupus drug was turned back and MeiraGTx picked up another gene therapy.

Original title: “FDA launches ‘PreCheck’ program; AstraZeneca, Acadia drugs set back”

The Public Health Service (PHS) Act directs HHS, through HRSA, to identify maternity care target areas (MCTAs; geographic areas within health professional shortage areas (HPSAs) that have a shortage of maternity care health professionals) for the purpose of assigning National Health Service Corps participants who are maternity care health professionals to HPSAs with a shortage of such professionals. On September 27, 2021, HRSA published a Federal Register notice (FRN) soliciting feedback on prop

Original title: “Request for Public Comment on the Updated Criteria for Determining Maternity Care Health Professional Target Areas”

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, such as when a PSO chooses to voluntar

Original title: “Patient Safety Organizations: Voluntary Relinquishment for the VizientTM PSO”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Original title: “Proposed Collection; 60-Day Comment Request; NCI Genomic Data Commons (GDC) Data Submission Request Form (National Cancer Institute)”

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

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the "generic" clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are "usually voluntary, low-burden, and uncontroversial collections," do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching p

Original title: “Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request”

(The Center Square) – Illinois lawmakers are pushing an amendment to ban restrictions or interference with a federal discount drug program. Speaking at a rally in Chicago on Sunday, state Rep. Anna Moeller, D-Elgin, sai... Wilbur said PhRMA would continue working with policy makers to advance federal solutions that protect patients and increase transparency. U.S. Rep. Danny Davis joined the rally in Chicago and urged Illinois House Speaker Emanuel “Chris” Welch, D-Hillside, to act. Pharmaceutical Research and Manufacturers of America Deputy Vice President of Public Affairs Tom Wilbur said the 340B program was created by Congress to help low-income and uninsured patients access medicines, but there is little evidence that patients are benefiting. “Instead, large tax-exempt hospitals and their for-profit partners are exploiting the program, buying medicines at steep discounts, and then marking them up by thousands of dollars. Across the country and here in Illinois, 340B is driving up costs for patients, taxpayers, and employers instead of providing savings reach those who need them most,” Wilbur told TCS. “Here’s your chance to give the people in Illinois that care for the most vulnerable people the resources that they need, because, of course, the state and the federal government falls very short on the reimbursement rates to take care of the patients,” Ford said.

Original title: “IL lawmakers push discount drug legislation to prevent restricted access | www.cities929.com”

The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the design of their facilities.

Original title: “FDA Launches PreCheck Program, Intended To Bring Manufacturers Home”

This final rule addresses a loophole in a regulatory statistical test applied to State proposals for Medicaid tax waivers. The test is designed to ensure, as required by statute, that non- uniform or non-broad-based health care-related taxes, authorized under a waiver, are generally redistributive. The inadvertent loophole currently allows some health care-related taxes, especially taxes on managed care organizations, to be imposed at higher tax rates on Medicaid taxable units than non-Medicaid

Original title: “Medicaid Program; Preserving Medicaid Funding for Vulnerable Populations-Closing a Health Care-Related Tax Loophole”

The Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH), in the Department of Health and Human Services, requests public input on priority topics related to firefighter safety and health. Through its Center for Firefighter Safety, Health, and Well-Being, NIOSH conducts research and provides services to identify and help prevent new and emerging hazards in the fire service earlier and faster. As the threat from structural, wildland urba

Original title: “National Institute for Occupational Safety and Health (NIOSH) Center for Firefighter Safety, Health and Well-Being Portfolio; Request for Information”

The Department of Health and Human Services (HHS) provides notice of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid.

Original title: “Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies”

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

Original title: “National Vaccine Injury Compensation Program; List of Petitions Received”

The Department of Health and Human Services (HHS or Department) published a notice of proposed rulemaking (NPRM) in the Federal Register on December 19, 2025. As a result of administrative technical issues, HHS is re-opening the public comment period for the public to submit comments. The purpose of the NPRM is to limit ambiguity by clarifying that the statutory exclusion of "gender identity disorders not resulting from physical impairments" from the scope of what constitutes discrimination incl

Original title: “Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance”

The Administration for Children and Families (ACF) is requesting public comments on a proposed information collection as part of the Safe Access for Victims' Economic Security (SAVES) Demonstration research on safety in the child support program. The SAVES Center, responsible for providing technical assistance and conducting evaluation for SAVES, will conduct one-time data collection activities with domestic violence (DV) survivors, advocates, and child support staff to understand their experien

Original title: “Proposed Information Collection Activity; Safe Access for Victims' Economic Security Data Collection for Safety in Child Support Program Research (New Collection)”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Original title: “Proposed Collection; 60-Day Comment Request; NCI Genomic Data Commons (GDC) Data Submission Request Form (National Cancer Institute)”

The U.S. Food and Drug Administration today began accepting requests to participate in the FDA PreCheck pilot program.

Original title: “FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing”

This report describes COVID-19 vaccine effectiveness among children ages 9 months to 17 years.

Original title: “Effectiveness of 2024–2025 COVID-19 Vaccines in Children in the United States — VISION, August 29, 2024–September 2, 2025”