The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #298 (VICH GL62) titled "Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance contributes to the international harmonization of methods used for

Original title: “Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availability”

HRSA will provide additional award funds to the Rural Residency Planning and Development Technical Assistance (RRPD-TA) Program recipient, the University of North Carolina at Chapel Hill, to provide additional technical assistance on rural graduate medical education and support the improvement of health care in rural areas.

Original title: “Notice of Supplemental Funding; Rural Residency Planning and Development Technical Assistance Program”

HRSA will provide additional award funds to the National Rural Health Policy, Community, and Collaboration Program recipient, the National Rural Health Association, to identify, engage, educate, and collaborate with rural stakeholders on national rural health issues and promising practices to improve health care in rural areas nationwide.

Original title: “Notice of Supplemental Funding, National Rural Health Policy, Community, and Collaboration Program”

HRSA will provide additional award funds to the National Rural Health Information Clearinghouse Program recipient under HRSA-25-009, the University of North Dakota, to provide information, data, and tools related to rural health to support improving health care in rural areas.

Original title: “Notice of Supplemental Funding, National Rural Health Information Clearinghouse Program”

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs)." FDA is issuing this draft guidance for submitters of certain PMAs to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). It introduces those submitters to the current publicly available resources and associated content developed to suppor

Original title: “Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability”

The Food and Drug Administration (FDA or Agency) is announcing the publication of a draft strategy document titled "BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document" (Strategy Document). This draft Strategy Document is intended to summarize the discussion that occurred at the FDA public workshop, "Advancing the Development of Interchangeable Products: Identifying Future Needs," held on September 19, 2025, and to describe FDA's future direction

Original title: “Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document”

Through the Supporting Healthy Start Performance Project cooperative agreement (HRSA-24-038), HRSA provides funding to the National Institute for Children's Health Quality (NICHQ) to provide technical assistance and support to Healthy Start Initiative (Healthy Start) award recipients. HRSA will provide supplemental award funds to NICHQ in Fiscal Year (FY) 2026 to support the implementation of the Healthy Start Self-Measured Blood Pressure Monitoring initiative for Healthy Start award recipients.

Original title: “Healthy Start Self-Measured Blood Pressure Monitoring”

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”

HRSA is providing supplemental award funds of $2,750,000 in federal fiscal year (FY) 2026 to ZERO TO THREE National Center for Infant, Toddler and Families, Inc., the current recipient of the Infant-Toddler Court Program (ITCP)--National Resource Center (NRC) cooperative agreement (HRSA-22-074). These funds will support the activities that strengthen child welfare and early childhood systems and advance early developmental health and well-being through the Infant-Toddler Court (ITC) approach. Su

Original title: “Infant-Toddler Court Program-National Resource Center”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH) 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; PHS Applications and Pre-Award Reporting Requirements (OD)”

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

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comments on proposed data collection projects, the 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: “Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report (OD)”

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

EURORDIS identifies where amendments could strengthen the EU Biotech Act. The post State of the EU Biotech Act: How it can still be improved appeared first on EURORDIS-Rare Diseases Europe.

Original title: “State of the EU Biotech Act: How it can still be improved”

Referred to the House Committee on Energy and Commerce.

Original title: “HRES 1561: Expressing support for the designation of the third week of September as "Fungal Disease Awareness Week" and encouraging efforts to improve awareness, diagnosis, treatment, surveillance, and prevention of fungal diseases in the United States.”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method." The guidance document provides recommendations on the development of blood collection, processing, and storage systems (e.g., blood bags with anticoagulant and additive solutions, empty bags for platelet pooling) intended for the man

Original title: “Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Guidance for Industry; Availability”

The Food and Drug Administration (FDA) is publishing an order setting forth its final determination regarding a partial exemption from the premarket notification requirements for radiology computer- aided detection and/or diagnosis devices and computer-aided triage and notification devices that was the subject of a notice published in the Federal Register of December 29, 2025. That notice announced FDA's receipt of a petition that requested exemption from the premarket notification requirements

Original title: “Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices”