The Promoting Life-saving New Therapies For Neonates Act Of 2015.pdf

BILLS-114s2041is.pdf
Preview of The Promoting Life-saving New Therapies for Neonates Act of 2015
🔗 Source: congress.gov
📊 Size: 237 KB
📄 Pages: 10 pages
⬇️ Downloads: 48

Summary

S. 2041 is a bill introduced to the US Senate to promote the development of safe drugs for neonates, which may be cited as the ‘‘Promoting Life-Saving New Therapies for Neonates Act of 2015’’. The bill amends the Federal Food, Drug, and Cosmetic Act to insert a new section that provides exclusivity to encourage the development of safe and effective therapies for neonates. It defines terms such as "neonatal drug" and "neonatal drug application" and establishes a system for issuing "neonatal drug exclusivity vouchers" to sponsors of approved neonatal drug applications. These vouchers entitle the holder to a transferable extension of existing patents and marketing exclusivities for a single human drug or biologic product. The voucher may be transferred to another sponsor, but not to a drug with expired patents and exclusivities. The Secretary of Health and Human Services may revoke the voucher if the neonatal drug product is not marketed in the US within 365 days of approval.

Description

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Technical Information

  • File Format: PDF
  • File Size: 237 KB
  • Pages: 10
  • Language: EN
  • Total Downloads: 48
  • Last Updated: 2 months ago

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