S 2030
114th Congress
Senate
Health
Drug safety, medical device, and laboratory regulation
Drug therapy
Genetics
Advancing Targeted Therapies for Rare Diseases Act of 2016
Introduced: September 15, 2015
Introduced by:
Bennet, Michael F.
Democratic
· Colorado
See on congress.gov
Everywhere this bill has been
5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 5, 2016
Placed on Senate Legislative Calendar under General Orders. Calendar No. 416.
Apr 5, 2016
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Feb 9, 2016
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Sep 15, 2015
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sep 15, 2015
Introduced in Senate
Plain-English 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).
What's happening now
Placed on Senate Legislative Calendar under General Orders. Calendar No. 416.
Committees of jurisdiction
1
Cosponsors
1