US SB2030 | 2015-2016 | 114th Congress

Status

Spectrum: Slight Partisan Bill (Republican 4-2)
Status: Introduced on September 15 2015 - 25% progression, died in chamber
Action: 2016-04-05 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 416.
Text: Latest bill text (Introduced) [PDF]

Summary

Advancing Targeted Therapies for Rare Diseases Act of 2016 (Sec. 2) 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 product of a mutated gene (e.g., the protein that causes cystic fibrosis).

Tracking Information

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Title

Advancing Targeted Therapies for Rare Diseases Act of 2016

Sponsors


History

DateChamberAction
2016-04-05SenatePlaced on Senate Legislative Calendar under General Orders. Calendar No. 416.
2016-04-05SenateCommittee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
2016-02-09SenateCommittee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
2015-09-15SenateRead twice and referred to the Committee on Health, Education, Labor, and Pensions.

Subjects


US Congress State Sources


Bill Comments

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