The law › Title 21, Food and Drugs › Chapter 9
21 U.S.C. 360aa: Recommendations for investigations of drugs for rare diseases or conditions
Created in 1983 by Public Law 97-414. Changed by 2 later laws. 1 bill in this Congress would change it.
- past change
- enacted this Congress
- proposed
This Congress
- H.R. 8205 Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 · sent to president · would change (c)
How it got here
1997
- Pub. L. 105–115, §125(b)(2)(G), struck out ", certification of such drug for such disease or condition under section 357 of this title," before "or licensing of such drug" in closing provisions. (Food and Drug Administration Modernization Act of 1997) Law text · (a)
- Pub. L. 105–115, §125(b)(2)(F), inserted "or" at end of par. (1), redesignated par. (3) as (2), and struck out former par. (2), which read as follows: "if the drug is an antibiotic, it may be certified for such disease or condition under section 357 of this title, or". (Food and Drug Administration Modernization Act of 1997) Law text · (a)
1985
- Pub. L. 99–91 struck out "or" at end of par. (1), inserted par. (2), redesignated former par. (2) as (3) and struck out "before" after "product,", and in last sentence inserted provisions relating to certification of such drug for disease or condition under section 357 of this title an… · (a)
Text, outline and history from the official U.S. Code (2024 edition) on GovInfo, published by the Office of the Law Revision Counsel. Changes made after that edition appear under This Congress.