Public Health Service Act Section 351

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.

Public health service act section 351. The biologics price competition and innovation act of 2009 bpcia amended section 351 k of the public health service act 42 u s c. Technical amendment a rule by the food and drug administration on 08 29 2000. 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.

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. Elimination of establishment license and product license. 262 k in providing ways to obtain licenses for certain biological products via abbreviated applications from the food and drug administration fda in order to market biosimilar products or interchangeable products for therapeutic uses.

Under section 351 a the submitted application must contain all the information regarding the safety and effectiveness of a biological product. Under 351 k 7 licensure of an 21 application for. Section 351 of the public health service phs act defines a biological product as a virus therapeutic serum toxin antitoxin vaccine blood blood component or derivative allergenic product.