The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "General Principles on Planning, Designing, Analyzing, and Reporting of Non- interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance outlines general principles on planning,

Original title: “M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines; International Council for Harmonisation; Guidance for Industry; Availability”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance updates the 2003 guidance titled "E2D Post- Approval Safety Data Management: Def

Original title: “E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports; International Council for Harmonisation; Guidance for Industry; Availability”

The Administration for Children and Families (ACF) is requesting a 3-year extension of the Children's Justice Act Program Instruction (Office of Management and Budget (OMB #0970-0425, expiration March 31,2026). There are no changes to the requirements, but the instructions have been streamlined to reduce burden, provide clarification, and improve data collection.

Original title: “Submission for Office of Management and Budget Review; Children's Justice Act Program Instruction”

The Administration for Children and Families (ACF) is requesting a 3-year extension of the form Low Income Home Energy Assistance Program (LIHEAP) Quarterly Reports (Office of Management and Budget (OMB) #: 0970-0589, expiration October 31, 2025). Changes are proposed, which would reduce redundancy and administrative burden for respondents.

Original title: “Submission for Office of Management and Budget Review; Low Income Home Energy Assistance Program (LIHEAP) Quarterly Reports”

The Administration for Children and Families (ACF) is requesting revisions and a one-year extension of the currently approved ACF Uniform Project Description (UPD) information collection (Office of Management and Budget (OMB) #: 0970-0139, March 31, 2026, expiration date). This includes transitioning to use one simplified version of the UPD with edits to the language for clarification and plain language purposes. Two versions of the instructions remain in the proposed simplified version to accom

Original title: “Submission for Office of Management and Budget Review; Administration for Children and Families Uniform Project Description”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment 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; Regular Clearance for the National Institute of Mental Health Data Archive (NDA), (NIMH)”

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC).

Original title: “Board of Scientific Counselors, National Center for Injury Prevention and Control; Notice of Charter Renewal”

The U.S. Food and Drug Administration today announced the issuance of 30 warning letters to telehealth companies for making false or misleading claims regarding compounded GLP-1 products offered on their websites.

Original title: “FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s”

Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (consideration: CR S1434; text: CR S1433)

Original title: “SRES 104: A resolution designating February 27, 2025, as "Rare Disease Day".”

Read twice and referred to the Committee on the Judiciary. (text: CR S735)

Original title: “S 3960: A bill to give Federal courts additional discretion to determine whether pretrial detention is appropriate for defendants charged with nonviolent drug offenses in Federal criminal cases.”

Read twice and referred to the Committee on Veterans' Affairs.

Original title: “S 3653: A bill to require the Secretary of Veterans Affairs to carry out efforts to inform veterans of their rights with regards to the receipt of health care, benefits, and services furnished under provisions of law administered by the Secretary, and for other purposes.”

Read twice and referred to the Committee on Commerce, Science, and Transportation.

Original title: “S 1885: A bill to require the Federal Trade Commission, with the concurrence of the Secretary of Health and Human Services acting through the Surgeon General, to implement a mental health warning label on covered platforms, and for other purposes.”

FDA decisions lack majority consensus, experts agree, possibly leading to less nuanced verdicts on new drug applications. This type of “fiat” decisionmaking, as multiple regulatory experts have called it, is also bleeding into the agency’s policymaking.

Original title: “FDA’s Circle of Trust Is Shrinking, Making Many Decisions Feel Like ‘Fiat’”

NIOSH conducts risk assessments to help control exposures in the workplace to reduce health risks.

Original title: “Occupational Risk Assessment”

The Morbidity and Mortality Weekly Report (MMWR) Series is prepared by the Centers for Disease Control and Prevention (CDC).

Original title: “Medscape CE”

Learn about clinical diagnosing and treating measles cases.

Original title: “Clinical Overview of Measles”

The National Institute for Health and Care Excellence (NICE) has published its first ever quality standard for rare diseases as part of an effort to speed up diagnosis and reduce variation in care across England and Wales.1 At the same time the government published its latest rare diseases ... The National Institute for Health and Care Excellence (NICE) has published its first ever quality standard for rare diseases as part of an effort to speed up diagnosis and reduce variation in care across England and Wales.1 At the same time the government published its latest rare diseases action plan for England, which includes new action to tackle health inequalities.2 This action plan highlights progress made in the past year, including a commitment by the Medicines and Healthcare Products Regulatory Agency to reform the regulation of rare therapies and the development of a new NHS framework for individualised genetic therapies. Wise J. Rare diseases: NICE lays out quality standard to improve diagnosis and treatment BMJ 2026; 392 :s432 doi:10.1136/bmj.s432

Original title: “Rare diseases: NICE lays out quality standard to improve diagnosis and treatment | The BMJ”

The Food and Drug Administration (FDA, the Agency, or we) is announcing the opening of a public docket to solicit information and comments on the Agency's series of guidances for industry on scale-up and postapproval changes (SUPAC) for specific dosage forms. Specifically, we are seeking comment on the following guidances for industry: "Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bi

Original title: “Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments”

This proposed information collection will use multiple methods to gather information from Tribal Leaders and Tribal Temporary Assistance for Needy Families (TANF) leaders, staff, and participants. The purpose of these activities is to gather systematic information directly from Tribal TANF program leaders, staff, and participants about (1) their challenges, successes, and support needs related to Tribal TANF data reporting requirements; and (2) their research and evidence needs related to Tribal

Original title: “Proposed Information Collection Activity; Next Steps for Tribal TANF Research and Data (New Collection)”

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