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42 U.S. Code § 300cc-14

Evaluation of certain treatments

42 U.S. Code § 300cc-14. Evaluation of certain treatments

(a) Establishment of program
(1) After consultation with the AIDS Research Advisory Committee established pursuant to section 300cc–3 of this title, the Secretary shall establish a program for the evaluation of drugs that—
(A)
are not approved by the Commissioner of Food and Drugs for the purpose of treatments with respect to acquired immune deficiency syndrome; and
(B)
are being utilized for such purpose by individuals infected with the etiologic agent for such syndrome.
(2)
The program established under paragraph (1) shall include evaluations of the effectiveness and the risks of the treatment involved, including the risks of foregoing treatments with respect to acquired immune deficiency syndrome that are approved by the Commissioner of Food and Drugs.
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