Vern Buchanan

“ To support the advanced manufacturing technologies program of the Food and Drug Administration, to establish National Centers of Excellence in Advanced Pharmaceutical Manufacturing, and for other purposes. ”

“ Evaluation Of An Advanced Manufacturing Technology.— “ (1) PACKAGE.—A sponsor who receives designation of an advanced manufacturing technology under this section shall provide the Secretary with a package of scientific evidence supporting the implementation of the advanced manufacturing technology in a particular context-of-use. “ (2) EVALUATION.—Within 90 days of receiving the package, the Secretary shall determine whether a designated advanced manufacturing technology is validated for the proposed context of use based on the scientific merit the supporting evidence provided by the sponsor. ”

“ SEC. 524B. ADVANCED MANUFACTURING TECHNOLOGIES PROGRAM.
“ (a) In General.—Not later than 1 year after the date of enactment of the Securing America’s Medicine Cabinet Act of 2021, the Secretary shall continue in effect the program to evaluate and approve new drug manufacturing technologies that are included in an application, or supplement to an application, for a drug under subsection (b) or (j) of section 505 of this Act or for a biological product submitted under subsection (a) or (k) of section 351 of the Public Health Service Act. ”