Sec. 3021. NOVEL CLINICAL TRIAL DESIGNS
386 words·~2 min read·
/statute-compilations/comps-13005/sec-3021A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 3021 NOVEL CLINICAL TRIAL DESIGNS **[**[21 U.S.C. 355 note](/us/usc/t21/s355)**]** ###
(a)Proposals for Use of Novel Clinical Trial Designs for Drugs and Biological Products For purposes of assisting sponsors in incorporating complex adaptive and other novel trial designs into proposed clinical protocols and applications for new drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and biological products under section 351 of the Public Health Service Act (42 U.S.C. 262), the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall conduct a public meeting and issue guidance in accordance with subsection (b). ###
(b)Guidance Addressing Use of Novel Clinical Trial Designs ####
(1)In general The Secretary, acting through the Commissioner of Food and Drugs, shall update or issue guidance addressing the use of complex adaptive and other novel trial design in the development and regulatory review and approval or licensure for drugs and biological products. ####
(2)Contents The guidance under paragraph
(1)shall address— #####
(A)the use of complex adaptive and other novel trial designs, including how such clinical trials proposed or submitted help to satisfy the substantial evidence standard under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)); #####
(B)how sponsors may obtain feedback from the Secretary on technical issues related to modeling and simulations prior to— ######
(i)completion of such modeling or simulations; or ######
(ii)the submission of resulting information to the Secretary; #####
(C)the types of quantitative and qualitative information that should be submitted for review; and #####
(D)recommended analysis methodologies. ####
(3)Public Meeting Prior to updating or issuing the guidance required by paragraph (1), the Secretary shall consult with stakeholders, including representatives of regulated industry, academia, patient advocacy organizations, consumer groups, and disease research foundations, through a public meeting to be held not later than 18 months after the date of enactment of this Act. ####
(4)Timing The Secretary shall update or issue a draft version of the guidance required by paragraph
(1)not later than 18 months after the date of the public meeting required by paragraph
(3)and finalize such guidance not later than 1 year after the date on which the public comment period for the draft guidance closes.
Connectionstraces to 2
Traces to 2 documents
Citation graph
cites case law
Cites 2Cited by 0 across 0 sources