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340B Final Rule Keeps Orphan Drug Exclusion Narrow, Counter To Manufacturers’ Request

 
• By Scott Steinke

HRSA’s final rule on the exclusion of orphan drugs from 340B discounts says the exclusion applies only to the FDA-designated orphan indication, not all uses of a drug with a rare-disease designation.

The HHS Health Resources and Services Administration’s final rule on how 340B requirements apply to drugs with orphan indications says that only the specific rare disease use will be exempted from mandatory discounts.

If the drug also has other non-orphan indications, its manufacturer must provide the 340B discounts when the product is used...

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More from North America

Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

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To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
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