2016-04-05 Reported to Senate amended 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).]]>

2015-09-15 Introduced in Senate 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).]]>

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