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Real-World Evidence Shows 82% Reduction in Infant RSV Hospitalizations With Nirsevimab

The results reinforce other real-world evidence from several broad infant immunization programs in the US, Spain, and France.

Federico martinon torresAdvisory committee on immunization practicesVaccine surveillance networkSukjai photoUniversitario santiagoImmunization practicesRoutine useProtect infantsYoung children against respiratory syncytialAddress shortage

Increased Development of RSV Immunoprophylaxis Inhibited by Cost and Acquisition Barriers

Despite the growth in vaccine and antibody development for combatting RSV, lower income countries may not reap the benefits.

United statesKatelyn galliPiotr rzymskiHealth alert networkAvailability of nirsevimabNational institute of allergyUniversity of connecticut school pharmacyMedical virologyConnecticut schoolSyncytial virusNational instituteAlert networkProtect infantsRespiratory syncytial virus

An Overview Of The US Food And Drug Administration s Legislative Goals (Part I) - Healthcare

In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency's most recent priorities as outlined in FDA's FY 2024 budget.

Agency regulatory oversight responsibilityAuthority for all drugsAuthority to require retention of dataDrug administrationAuthority regardingDietary supplement healthAuthority to protect infantsHealth careEnvironmental protection agencyFiscal yearFederal foodCosmetic actAll hazards preparedness actProtect infantsProduct testing requirementsFoods marketed

An Overview of the US Food and Drug Administration s Legislative Goals (Part I) | K&L Gates LLP

In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined.

Authority to protect infantsAgency regulatory oversight responsibility for certain productsKl gate health careDietary supplement healthEnvironmental protection agencyAuthority for all drugsDrug administrationAuthority regardingAuthority to require retention of dataKl gatesFiscal yearFederal foodCosmetic actAll hazards preparedness actProtect infantsProduct testing requirements

FDA s FY 2024 Priorities Overview and Insights

FDA s FY 2024 Priorities Overview and Insights
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Authority to protect infantsAuthority to require retention of dataAuthority for all drugsEnvironmental protection agencyDietary supplement healthAgency regulatory oversight responsibility for certain productsAuthority regardingDrug administrationKl gate health careFiscal yearFederal foodCosmetic actAll hazards preparedness actProtect infantsProduct testing requirementsFoods marketed

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