Advancing Targeted Therapies for Rare Diseases Act of 2016

Summary

Advancing Targeted Therapies for Rare Diseases Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to permit the Food and Drug Administration to allow the sponsor of a new drug or biological product for the treatment of a rare, serious condition to rely upon information submitted for an approved medication that uses the same technology. For a sponsor to be eligible to rely upon submitted information: (1) the sponsor must have developed, or have a right of reference to, the relied upon information; and (2) the new medication must use nucleic acids (e.g., DNA) or similar chemicals, or must affect a disease-causing protein variant (e.g., the protein that causes cystic fibrosis).

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Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 5 April 2016

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• Reported to Senate (PDF)

  Reported to Senate · EN · 5 April 2016

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• Reported to Senate with amendment(s)

  summary · EN · 5 April 2016

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• Introduced in Senate (text)

  Introduced in Senate · EN · 15 September 2015

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 15 September 2015

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• Introduced in Senate

  summary · EN · 15 September 2015

  Open at official source

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