Sec. 3041. Clarifying FDA postmarket authorities
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Section 505–1(b)(1)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(b)(1)(E) ) is amended by striking of the drug and inserting of the drug, which may include reduced effectiveness under the conditions of use prescribed in the labeling of such drug, but which may not include reduced effectiveness that is in accordance with such labeling . Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(4) ) is amended— in subparagraph
(A)by— striking and inserting Safety information ; and Safety or new effectiveness information by striking If the Secretary becomes and all that follows through in the labeling of the drug and inserting If the Secretary becomes aware of new information, including any new safety information or information related to reduced effectiveness, that the Secretary determines should be included in the labeling of the drug ; in clause
(i)of subparagraph (B), by inserting before the semicolon , or new effectiveness information ; in subparagraph
(C)by striking safety information and inserting safety or new effectiveness information ; and in subparagraph
(E)by striking safety information and inserting safety or new effectiveness information . Not less than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance regarding the circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials to assess the potential reduction in effectiveness of a drug and how such reduction in effectiveness could result in a change to the benefits of the drug and the risks to the patient. Such guidance shall also address how the Food and Drug Administration may apply this section and the amendments made thereby with respect to circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials and safety labeling changes related to the use of controlled substances for acute or chronic pain.
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- 21 USC 355–1(b)(1)(E)
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