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Bill114th CongressFiled Sep 15, 2015Health
S. 2030

Advancing Targeted Therapies for Rare Diseases Act of 2016

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What it doesSummary reported to senate with amendment(s) (Apr 5, 2016)

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).

What just happenedApr 5, 2016

Placed on Senate Legislative Calendar under General Orders. Calendar No. 416.

Who’s behind it

Sen. Bennet, Michael F. [D-CO](D-CO)Sponsor
5 cosponsors1 D4 R
Read on Congress.gov
5cosponsors1committees6actions1related bills3subjects
  1. Apr 5, 2016Calendars

    Placed on Senate Legislative Calendar under General Orders. Calendar No. 416.

  2. Apr 5, 2016Committee

    Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.

    Health, Education, Labor, and Pensions Committee
  3. Apr 5, 2016Committee14000

    Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.

    Health, Education, Labor, and Pensions Committee
  4. Feb 9, 2016Committee

    Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

    Health, Education, Labor, and Pensions Committee
  5. Sep 15, 2015IntroReferral

    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

    Health, Education, Labor, and Pensions Committee
  6. Sep 15, 2015IntroReferral10000

    Introduced in Senate

Reported to Senate with amendment(s)Apr 5, 20161

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).
Introduced in SenateSep 15, 2015

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).
Advancing Targeted Therapies for Rare Diseases Act of 2016 — Informed