The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have published their first report tracking progress against the EU’s new clinical trial targets.…

Original title: “EU tracks progress towards 2030 clinical trial targets”

This final rule contains provisions to improve implementation of the Patient Protection and Affordable Care Act, including payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2027 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This final rule also includes provisions related to

Original title: “Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program”

The EHIgnite Challenge addresses data usability challenges in single patient electronic health information (EHI) exports. This challenge seeks to incentivize the development of tools, platforms, and workflows that transform single patient EHI exports into usable, readable, and actionable information that supports clinical care, patient engagement, and informed decision-making.

Original title: “Announcement of Requirements and Registration for “EHIgnite Challenge””

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

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

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 4540: A bill to amend the Public Health Service Act to improve reproductive health care of individuals with disabilities.”

Despite having no definitive data, Sen. Ron Johnson (R-WI) in a letter to health secretary Robert F. Kennedy, Jr. suggested there was a conscious effort by the Biden administration’s FDA to cover up the safety risks of COVID-19 vaccines.

Original title: “FDA’s own report shows no child deaths definitively caused by COVID vaccination”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 4519: Medical Device Electronic Labeling Act”

In accordance with the requirements of the Privacy Act of 1974, as amended (Privacy Act) (5 U.S.C 552a), HHS is establishing a new system of records, 09-15-0070, "Graduate Medical Education (GME) Full-Time Equivalent (FTE) Resident Assessment Records," to be maintained by, and on behalf of, HRSA. The system of records will contain records about medical and dental residents training in children's hospitals and teaching health centers, which are used to justify the number of residents counted in c

Original title: “Privacy Act of 1974; System of Records”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Center for Scientific Review (CSR) National Institutes of Health will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Original title: “Submission for OMB Review; 30-Day Comment Request; Early Career Reviewer Program Online Application and Vetting System (Center for Scientific Review)”

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a virtual meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB); the main focus of the meeting is to solicit feedback from council members on the 2026-2031 National Action Plan on Combating Antibiotic Resistant Bacteria. The meeting will be open to the public as a live streamed event on hhs.gov/liv

Original title: “Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria”

Pursuant to the Public Health Service Act, as amended, and the Federal Advisory Committee Act, as amended, the Centers for Disease Control and Prevention (CDC) announces the re-establishment of the Advisory Committee on Immunization Practices (ACIP). A notice of committee charter renewal for the ACIP, which was published in the Federal Register on April 6, 2026, is hereby withdrawn. In this document, the CDC also announces the determination that the re- establishment of the ACIP is necessary and

Original title: “Advisory Committee on Immunization Practices (ACIP); Notice of Charter Re-Establishment”

The EveryLife Foundation for Rare Diseases submitted a response to the Centers for Disease Control and Prevention (CDC) in response to the agency’s Request for Information (RFI) on developing new […] The post  EveryLife Foundation Urges CDC to Adopt Streamlined, Patient‑Centered Process for ICD‑10 Codes for Rare and Genetic Diseases appeared first on EveryLife Foundation for Rare Diseases.

Original title: “ EveryLife Foundation Urges CDC to Adopt Streamlined, Patient‑Centered Process for ICD‑10 Codes for Rare and Genetic Diseases”

The FDA has previously linked eight deaths in the U.S. to Tavneos and has alleged that doctored data were used to support its 2021 approval.

Original title: “Amgen’s rare disease drug Tavneos tied to 20 deaths in Japan”

After less than three weeks on the job, Katherine Szarama is being replaced by Karim Mikhail as acting head of the Center for Biologics Evaluation and Research. Mikhail had previously spent more than 20 years at Merck and joined the FDA last year.

Original title: “Prasad ally Szarama exits CBER after 3 weeks as FDA cleanout continues”

The FDA has introduced models intended to accelerate rare disease drug development, but recent reversals of guidance from the agency speak to a lack of clarity in its implementation. AI can help focus this process.

Original title: “FDA alignment is critical to serving the rare disease community. AI can help”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 4550: Maternal Health Pandemic Response Act”

Original title: “Agency for Healthcare Research and Quality Statement of Delegation of Authority”

The Administration for Children and Families (ACF) is requesting a 3-year extension of the information collection Case Plan Requirement, Title IV-E of the Social Security Act, (Office of Management and Budget (OMB) #: 0970-0428, expiration September 30, 2026). There are no changes to the requirements, but burden estimates have been updated to reflect a reduction in average time to complete a case plan and the current numbers of children in foster care.

Original title: “Submission for Office of Management and Budget Review; Case Plan Requirement, Title IV-E of the Social Security Act”