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Congress Year-End Appropriations Package Brings FDA Legislative Changes, Leaves Unresolved Policy Issues - Life Sciences, Biotechnology & Nanotechnology

In a break with past precedent, last year's Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes.

United statesDevice manufacturer communications with payorsExchange of product information prior to approvalPharmaceuticals for childrenOffice of critical foodsPublic health serviceAccountability officeAdvancement pilot programSenate healthClinical laboratory improvementProgram reauthorizationsConsolidated appropriations actPresident bidenDrug omnibus reform actEmerging new threatsPandemics act

Results of Biden Signing the Consolidated Appropriations Act

President Biden signed into law the Consolidated Appropriations Act for 2023, colloquially referred to as the omnibus funding bill, that includes a similarly expansive and diverse piece of legislation called the Food and Drug Omnibus Reform Act.

Public health serviceNational centers of excellenceApproval councilDrug administrationExchange of product information prior to approvalTechnology programPresident bidenConsolidated appropriations actDrug omnibus reform actFederal foodCosmetic actAccelerated approval councilFederal cosmeticCosmetics regulation actOnline retail marketplacesTechnical amendments

Congress Year-End Appropriations Package Brings FDA Legislative Changes, Leaves Unresolved Policy Issues | Akin Gump Strauss Hauer & Feld LLP

In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate.

United statesAkin gump strauss hauer feldRare disease endpoint advancement pilot programDevice manufacturer communications with payorsDrug administrationPharmaceuticals for childrenExchange of product information prior to approvalPublic health serviceOffice of critical foodsClinical laboratory improvement amendmentsSenate appropriationsProducts grants programGovernment accountability officeSenate healthProgram reauthorizationsAkin gump strauss hauer

Congress Expands Pathway for Drug & Device Manufacturers Pre-Approval Communication of Health Care Economic Information to Payors, Formularies, & Similar Entities | Goodwin

The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 ( “PIE Act”) was passed as part of Congress’s December 23, 2022 omnibus spending bill. Once.

Us government accountability officeDrug administration modernizationPublic health serviceDrug administrationExchange of product information prior to approvalApproval information exchangePre approval information exchange actFederal foodCosmetic actDrug administration modernization actProduct information priorPublic health service actAccountability office

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