21 U.S. Code § 360aa - Recommendations for investigations of drugs for rare diseases or conditions
The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).
1997—Subsec. (a). 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.
Subsec. (a)(1) to (3). 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”.
1985—Subsec. (a). 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 and substituted “licensing of such drug for such disease or condition under section 262 of title 42” for “licensing under section 262 of title 42 for such disease or condition”.
Pub. L. 100–290, § 3(d), Apr. 18, 1988, 102 Stat. 91, directed Secretary of Health and Human Services to conduct a study to determine whether the application of subchapter B of chapter V of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360aa et seq. (relating to drugs for rare diseases and conditions), and 26 U.S.C. 28 (relating to tax credit) to medical devices or medical foods for rare diseases or conditions or to both was needed to encourage development of such devices and foods and report results of the study to Congress not later than one year after Apr. 18, 1988.
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