2026 · 1st Quarter (Jan 1 - Mar 31)
Filed by ALSTON & BIRD LLP.
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Literal source text
Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs. Most-Favored Nation and International Reference Pricing proposals. PDUFA/regulatory review process.
Literal federal measure citations: H.R.946
Support for H.R.946, Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act). Legislation regarding the Orphan Drug Act and rare disease diagnosis, treatment, and care. Legislation regarding kidney disease and in particular rare kidney disease. Legislation regarding newborn screening. H.R.1518, New Era of Preventing End-Stage Kidney Disease Act. Support of reauthorization of priority review voucher program. Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs.
H.R.1518, New Era of Preventing End-Stage Kidney Disease Act. Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs, Medicare and Medicaid.
Literal federal measure citations: H.R.1518
Legislation regarding clinical research for rare diseases and orphan drug development, and the Accelerated Approval pathway. H.R.1262/S.932, Give Kids a Chance Act to renew PRV program. Related provisions in Pub. L. No. 119-21, One Big Beautiful Bill Act. The Newborn Screening Reauthorization Act. Importance of patient voice in rare kidney disease.
H.R.1414, Camerons Law, to restore the amount of the Orphan Drug Tax Credit. Pub. L. No. 119-21, One Big Beautiful Bill Act, provisions regarding orphan drugs.
Literal federal measure citations: H.R.1414
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