Section 351 Of The Public Health Service Act

These products are called 361 products because they are regulated under section 361 of the public health service phs act.

Section 351 of the public health service act. 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. 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.

Start part part 56 institutional review boards. 262 k as added by this act and on a biennial basis thereafter until october 1 2013 the secretary shall perform an audit of the costs of reviewing such. 107 188 142 a 1 2 b 1 and c which directed certain amendments to section 361 of the public health act was executed by making the amendments to this section which is section 361 of the public health service act to reflect the probable intent of congress see below.

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. E combination product includes. If a reference product as defined in section 351 of the public health service act 42 u s c.

360bb for a rare disease or condition a. On the date that is 2 years after first receiving a user fee applicable to an application for a biological product under section 351 k of the public health service act 42 u s c. The biologics price competition and innovation act of 2009 bpcia amended section 351 k of the public health service act 42 u s c.

107 188 142 a 1 substituted executive orders of. 111 148 title vii 7002 h mar. 351 products 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.

As discussed below these two pathways differ markedly in terms of the. The authority citation for 21 cfr part 56 continues to read as follows. 262 as amended by this act has been designated under section 526 of the federal food drug and cosmetic act 21 u s c.