Advancing Targeted Therapies for Rare Diseases Act of 2016

1/11/2023, 1:29 PM

Congressional Summary of S 2030

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).

Current Status of Bill S 2030

Bill S 2030 is currently in the status of Bill Introduced since September 15, 2015. Bill S 2030 was introduced during Congress 114 and was introduced to the Senate on September 15, 2015.  Bill S 2030's most recent activity was Placed on Senate Legislative Calendar under General Orders. Calendar No. 416. as of April 5, 2016

Bipartisan Support of Bill S 2030

Total Number of Sponsors
1
Democrat Sponsors
1
Republican Sponsors
0
Unaffiliated Sponsors
0
Total Number of Cosponsors
5
Democrat Cosponsors
1
Republican Cosponsors
4
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill S 2030

Primary Policy Focus

Health

Potential Impact Areas

Drug safety, medical device, and laboratory regulationDrug therapyGenetics

Alternate Title(s) of Bill S 2030

Advancing Targeted Therapies for Rare Diseases Act of 2016A bill to allow the sponsor of an application for the approval of a targeted drug to rely upon data and information with respect to such sponsor's previously approved targeted drugs.Advancing Targeted Therapies for Rare Diseases Act of 2015Advancing Targeted Therapies for Rare Diseases Act of 2016
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