21 U.S.C. § 360a–1 — Clinical trials

(a) Review and revision of guidance documents (1) In general Each year, the Secretary must review, and revise where appropriate, at least 3 FDA guidance documents. This includes (A) reviewing FDA's guidance on how to run clinical trials for antibacterial and antifungal drugs, and (B) updating those documents, where appropriate, to reflect new scientific and medical developments and to make the approval procedures and requirements under chapter V of the Federal Food, Drug, and Cosmetic Act clearer. (2) Issues for review At a minimum, this yearly review must cover: the right animal models of infection, in vitro (lab) testing techniques, valid microbiological surrogate markers, whether to use noninferiority trials or superiority trials, how trials enroll patients, what data the trials must collect, and the correct "delta" values — the allowed margin of difference — for noninferiority trials. (3) Rule of construction Except for the updates the Secretary makes under (1)(B), nothing in this section cancels or changes FDA's existing guidance documents. (b) Recommendations for investigations (1) Request The sponsor of a drug meant to be designated a "qualified infectious disease product" can ask the Secretary for written recommendations. The sponsor wants to know what non-clinical and clinical investigations the Secretary believes may be needed before the drug can be approved under section 505 of the Federal Food, Drug, and Cosmetic Act, for treating, detecting, preventing, or identifying a "qualifying pathogen" — a term defined in section 505E of that Act. (2) Recommendations If the Secretary has reason to believe the drug really is a qualified infectious disease product, the Secretary must give the sponsor written recommendations. Those cover the non-clinical and clinical investigations the Secretary believes, based on the information available at the time of the request, would be necessary for approval for the use described in paragraph (1). (c) Qualified infectious disease product In this section, "qualified infectious disease product" has the meaning given in section 505E(g) of the Federal Food, Drug, and Cosmetic Act.