HHS proposes a rule to prohibit Medicare and Medicaid certified hospitals from performing sex-rejecting procedures on children, aiming to enhance child health and safety. This decision reflects a review of recent safety and efficacy data regarding these procedures.

The Department of Health and Human Services proposes a rule to revise nondiscrimination regulations under section 504 of the Rehabilitation Act, impacting programs receiving federal funding. This NPRM aims to enhance protections for individuals with disabilities in health-related programs.

FDA has approved KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) under a rare pediatric disease priority review voucher. This approval highlights the agency's commitment to expedite access for treatments addressing rare pediatric conditions.

FDA has issued a priority review voucher for FORZINITY (elamipretide), a product for a rare pediatric disease, enhancing its market potential. This voucher incentivizes the development of treatments for rare conditions, aligning with FDA's commitment to expedite access for patients.

A proposed rule by HHS aims to prohibit Medicaid and CHIP funding for sex-rejecting procedures for individuals under 18. This policy could significantly impact access to care for transgender youth across states.

The FDA confirms that Dexchlorpheniramine Maleate oral syrup was not withdrawn for safety or effectiveness reasons, allowing continued approval of abbreviated new drug applications (ANDAs) for this product. This decision supports ongoing market availability for this antihistamine.

The FDA confirms that EFFEXOR XR (venlafaxine hydrochloride) 100 mg was not withdrawn for safety or effectiveness reasons, allowing continued approval of abbreviated new drug applications (ANDAs) referencing this product. This decision ensures ongoing market access for generic versions of the medication.

The FDA has classified the electrical tongue nerve stimulator for treating motor deficits as a Class II device, which will include special controls. This classification aims to ensure safety and effectiveness for patients with motor deficits.

The CDC is reopening the public comment period for an RFI on CAUTI events among patients with spinal cord injury-associated neurogenic bladder. This initiative aims to gather insights on the burden of CAUTIs in this population and improve reporting practices.

The Commission on Laboratory Accreditation (COLA) has been granted deeming authority as an accreditation organization for Clinical Cytogenetics and Radiobioassay under the Clinical Laboratory Improvement Amendments of 1988. This approval signifies that COLA meets the necessary CLIA requirements for these specialties.

The HHS has rescinded the requirement for Head Start programs to implement a COVID-19 mitigation policy, as outlined in the January 2023 final rule. This change may impact operational protocols in early childhood education settings.

NORD CEO Pamela Gavin expresses disappointment over the Senate's failure to advance the Give Kids a Chance Act, which has seen significant advocacy from rare disease supporters. This setback highlights ongoing challenges in legislative support for rare disease initiatives.

NIH seeks public input on proposed revisions to its Genomic Data Sharing Policy, aiming to establish clearer requirements for controlled-access data. This initiative could significantly impact how human participant research data is managed and shared.

FDA has released final guidance on the use of real-world evidence (RWE) to support regulatory decision-making for medical devices. This guidance clarifies the evaluation of real-world data (RWD) quality, which is crucial for regulatory processes.

The CDC awards a $1.6 million grant to the University of Southern Denmark to study optimal timing and delivery of monovalent Hepatitis B vaccinations for newborns in Guinea-Bissau. This five-year project aims to enhance vaccination strategies in low-resource settings.

The U.S. Department of Health and Human Services is seeking approval for a new evaluation report template for the Personal Responsibility Education Program (PREP) Innovative Strategies (PREIS). This template will guide PREIS grantees in documenting their local evaluations and findings.

The Administration for Children and Families' Office of Refugee Resettlement plans to continue data collection on the Services for Survivors of Torture program. This initiative aims to gather demographic and outcome data from grant recipients to improve program performance.

The FDA has released a draft guidance document addressing mandatory recalls for cosmetics, aimed at clarifying the agency's authority and implementation criteria. This guidance is intended to assist the regulated industry in understanding compliance requirements.