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

The U.S. Food and Drug Administration today awarded national priority vouchers under the Commissioner’s National Priority Voucher (CNPV) pilot program to two investigational products for their potential to increase access through affordability for American patients.

Original title: “FDA Grants Two National Priority Vouchers”

The U.S. Food and Drug Administration has issued a Request for Information (RFI) seeking input from venture capital firms on developing a new contracting approach to strengthen collaboration between the agency and America’s most innovative companies.

Original title: “FDA Explores New Contracting Approach to Advance Public Health Innovation”

2025 was a special year for EMA, its staff and the whole European Medicine…, Second, we will intensify our support for innovation for public and animal health. We will further enhance our early development support to enable new medicines to be…

Original title: “Emer Cooke, EMA’s Executive Director: 2025 achievements in medicine regulation”

The Management Board opened its meeting welcoming the political agreement reached by the European Commission, the European Parliament and the Council of the European Union…

Original title: “EMA Management Board: highlights of December 2025 meeting”

EMA's office is closed from 18:00 on Monday 22 December 2025 to 08:30 on Monday 5 January 2026.Outside of working hours and on public holidays, it is possible to call our…

Original title: “EMA business hours over holiday period”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Processes and Practices Applicable to Bioresearch Monitoring Inspections." This final guidance is being issued to comply with the Food and Drug Omnibus Reform Act of 2022, which directs the Agency to issue guidance describing the processes and practices applicable to inspections of sites and facilities inspected under FDA's Bioresearch Monitoring inspection program, to the e

Original title: “Processes and Practices Applicable to Bioresearch Monitoring Inspections; Guidance for Industry; Availability”

The Department of Health and Human Services (HHS or Department) issues this Notice of Proposed Rulemaking (NPRM) to revise 45 CFR 84.4(g) in the regulation implementing section 504 of the Rehabilitation Act of 1973 (section 504) as it applies to recipients of HHS funding (entitled "Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance," 89 FR 40066 ("2024 Final Rule")), published on May 9, 2024. This rule clarifies that the Department inter

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

This proposed rule would revise the requirements that Medicare and Medicaid certified hospitals must meet to participate in the Medicare and Medicaid programs. These changes are necessary to protect the health and safety of children and reflect HHS' review of recent information on the safety and efficacy of sex-rejecting procedures (SRPs) on children. The revisions to the requirements would prohibit hospitals from performing sex-rejecting procedures on children.

Original title: “Medicare and Medicaid Programs; Hospital Condition of Participation: Prohibiting Sex-Rejecting Procedures for Children”

This proposed rule would require that a State Medicaid plan must provide that the Medicaid agency will not make payment under the plan for sex-rejecting procedures for children under 18 and prohibit the use of Federal Medicaid dollars to fund sex-rejecting procedures for individuals under the age of 18. In addition, it would require that a separate State Children's Health Insurance Program (CHIP) plan must provide that the CHIP agency will not make payment under the plan for sex-rejecting proced

Original title: “Medicaid Program; Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Sex-Rejecting Procedures Furnished to Children”

This direct final rule (DFR) removes the requirement that Head Start programs have a COVID-19 mitigation policy. This requirement was included in the final rule titled "Mitigating the Spread of COVID-19 in Head Start Programs," which ACF published on January 6, 2023. Specifically, this rescission removes the requirement from the Head Start Program Performance Standards (Performance Standards) that Head Start programs have a COVID-19 mitigation policy developed in consultation with their Health a

Original title: “COVID-19 Mitigation Policy Requirement in Head Start Programs; Recission”

This notice announces the application of the Commission on Laboratory Accreditation (COLA) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the specialties of Clinical Cytogenetics and Radiobioassay. We have determined that COLA meets or exceeds the applicable CLIA requirements. Consequently, we are granting COLA deeming authority for the specialties of Clinical Cytogenetics and Radiobioassay f

Original title: “Announcement of the Approval of COLA as an Accreditation Organization for the Specialties of Clinical Cytogenetics and Radiobioassay Under the Clinical Laboratory Improvement Amendments of 1988”

The Food and Drug Administration (FDA, Agency, or we) has determined that DEXCHLORPHENIRAMINE MALEATE (dexchlorpheniramine maleate, oral syrup, 2 milligrams (mg)/5 milliliters (ml)), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as th

Original title: “Determination That DEXCHLORPHENIRAMINE MALEATE (Dexchlorpheniramine Maleate, Oral Syrup, 2 Milligrams/5 Milliliters) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness”

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), is reopening the public comment period for a request for information (RFI) that was initially published on September 8, 2025, regarding Catheter-associated Urinary Tract Infections (CAUTIs) among patients with Spinal Cord Injury-associated Neurogenic Bladder (SCI- NB). We want to understand better the burden of CAUTIs among this patient population and any implications related to reporting

Original title: “CAUTI Events Among Patients With Spinal Cord Injury-Associated Neurogenic Bladder (SCI-NB); Request for Information: Reopening of Comment Period”

The Food and Drug Administration (FDA or Agency) has determined that EFFEXOR XR (venlafaxine hydrochloride) extended-release capsule, 100 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and r

Original title: “Determination That EFFEXOR XR (Venlafaxine Hydrochloride) Extended-Release Capsule, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness”

Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has renamed the Office of Child Support Services. This notice changes the name of the office from Office of Child Support Services (OCSS) to Office of Child Support Enforcement (OCSE).

Original title: “Statement of Organization, Functions, and Delegations of Authority”

The National Institutes of Health (NIH) is requesting public input on its proposal to establish harmonized and transparent policy requirements for protecting human participant research data. Specifically, NIH proposes (1) establishing policy requirements for which data should be controlled-access under NIH data sharing policies, and (2) revising the NIH Genomic Data Sharing Policy to simplify and harmonize requirements.

Original title: “NIH Controlled-Access Data Policy and Proposed Revisions to NIH Genomic Data Sharing Policy”

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance entitled "Use of Real- World Evidence to Support Regulatory Decision-Making for Medical Devices." FDA is issuing this guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This final guidance supersedes the final guidanc

Original title: “Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance document entitled "Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry." The draft guidance document, when finalized, will provide answers to common questions that might arise about FDA's mandatory recall authority for cosmetics. It is intended to inform regulated industry about the Agency's current thinking on implementation of certain aspects, including the criteri

Original title: “Questions and Answers Regarding Mandatory Cosmetics Recalls: Draft Guidance for Industry; Availability”

The Administration for Children and Families' (ACF) Office of Refugee Resettlement (ORR) intends to continue collecting demographic, programmatic, and outcome data on Services for Survivors of Torture (SOT) grant recipients and the clients they serve. ORR collects information from the grantee cohort under the Survivors of Torture Program Data Points (PDP) and Program Performance Progress Report (PPR) (Office of Management and Budget (OMB) #: 0970-0599; Expiration date: February 28, 2026) to lear

Original title: “Proposed Information Collection Activity; Office of Refugee Resettlement Services for Survivors of Torture Program Data Points and Performance Progress Report”