Section 351 Public Health Service Act

1 a product comprised of two or more.

Section 351 public health service act. Sections 351 and 361 of the public health service act phsa provides the authority for fda to establish regulatory requirements for marketing traditional biologics and human cells tissues and cellular and tissue based products hct ps. As discussed below these two pathways differ markedly in terms of the time effort and expense required to bring these products to market in the u s. 351 a is the traditional pathway for approval of biologics and innovator biologics under the public health service phs act.

19 351 k 7 c of the public health service act phs act as added by the biologics price 20 competition and innovation act of 2009 bpci act. In contrast if a cell therapy product does not meet all the criteria outlined in 21 cfr 1271 10 a then it is regulated as a drug device or biological product under the federal food drug and cosmetic act fdca and section 351 of the phs act. Implementation of biologics license.

D biological product has the meaning given the term in section 351 a of the public health service act 42 u s c. Under 351 k 7 licensure of an 21 application for. Biological products regulated under section 351 of the public health service act.

E combination product includes. Elimination of establishment license and product license.