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Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Energy & Commerce committee ranking member Diana DeGette.
Original title: “FDA disavows Makary, Prasad’s papers as lawmaker blasts ‘shoot-from-the-hip’ policymaking”
Became Public Law No: 119-69.
Original title: “S 222: Whole Milk for Healthy Kids Act of 2025”
The FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversight and quality controls remain essential.
Original title: “FDA’s first AI-focused cGMP warning letter signals new scrutiny for manufacturers”
Clinical laboratory testing technology has advanced significantly since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations were implemented in 1992. This request for information (RFI) seeks input from the public regarding various topics related to the CLIA regulations, including: breath testing; laboratory processes and procedures; emergency preparedness, biosafety and biosecurity, and cybersecurity; and specialty testing areas. Responses to this RFI may be used to help in
Original title: “Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations”
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, when a PSO chooses to voluntarily reli
Original title: “Patient Safety Organizations: Expired Listing for the Informed Patient Safety Organization (IPSO)”
The Food and Drug Administration (FDA or Agency) is announcing the process for FDA to issue Data Requests for the submission of data from the public to help inform certain future over-the counter (OTC) monograph drug activities, including development of FDA-initiated proposed orders to modify conditions described in an OTC monograph. FDA is issuing this notice to inform the public and interested parties of the process that FDA is implementing to issue these Data Requests.
Original title: “Process for FDA Data Requests To Inform Certain Over-the-Counter Monograph Drug Activities; Procedure”
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces it is issuing an Order under Section 362 and 365 of the Public Health Service Act, and associated implementing regulations, continuing the suspension of the right to introduce certain persons from countries where an outbreak of a quarantinable communicable disease exists. This Order was issued on July 13, 2026, and shall remain in effect through 4:59 p.m. Eastern Dayl
Original title: “Order Under Sections 362 and 365 of the Public Health Service Act Continuing the Suspension of the Right To Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease Exists”
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, but without an oral public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. The public is also welcome to listen to the meeting by joining the audio conference (information below). The audio
Original title: “Meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health”
The Children's Bureau (CB), Administration for Children and Families (ACF) is requesting a 3-year extension of the collection of information under the Child and Family Services Plan (CFSP), the Annual Progress and Services Report (APSR), and the Annual Budget Expenses Request and Estimated Expenditures (Child and Family Services (CFS)- 101) collection (Office of Management and Budget #: 0970-0426, expiration July 31, 2026). There are minor changes to the CFS-101 form and changes to the way the i
Original title: “Submission for Office of Management and Budget Review; Child and Family Services Plan, Annual Progress and Services Report, and Annual Budget Expenses Request and Estimated Expenditures (Child and Family Services-101)”
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), Department of Health and Human Services, is proposing to collect data for a new implementation and outcomes study, Evaluation of the Next Generation Child Support Employment Services Demonstration (NextGen).
Original title: “Submission for Office of Management and Budget Review; Evaluation of the Next Generation Child Support Employment Services Demonstration”
Read twice and referred to the Committee on Finance.
Original title: “S 2329: Medicare Orthotics and Prosthetics Patient-Centered Care Act”
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Original title: “S 3254: NIH IMPROVE Act”
Read twice and referred to the Committee on the Judiciary.
Original title: “S 4879: Let Doctors Provide Reproductive Health Care Act”