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).| Action Date | Type | Text | Source |
|---|---|---|---|
| 2016-04-05 | Calendars | Placed on Senate Legislative Calendar under General Orders. Calendar No. 416. | Senate |
| 2016-04-05 | Committee | Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. | Senate |
| 2016-02-09 | Committee | Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. | Senate |
| 2015-09-15 | IntroReferral | Read twice and referred to the Committee on Health, Education, Labor, and Pensions. | Senate |
| 2015-09-15 | IntroReferral | Introduced in Senate | Library of Congress |