000			02172ngm a2200445 a 4500
001			HST5636
003			UkLoHST
006			m c
007			cr|cna|||a||||
007			vz|czazum
008			211204s2021 enk|||||||||||s|||v|eng d
028	5	0	_a5636 _bHenry Stewart Talks
035			_a(UkLoHST)4793
040			_aUkLoHST _beng _cUkLoHST
100	1		_aLapteva, Larissa, _u(Center for Biologics Evaluation and Research, FDA, USA) _4spk
245	1	0	_aDevelopment and regulation of cellular and gene therapy products _h[electronic resource] : _bFDA perspective / _cLarissa Lapteva.
260			_aLondon : _bHenry Stewart Talks, _c2021.
300			_a1 online resource (1 streaming video file (51 min.) : _bcolor, sound).
490	1		_aThe biomedical & life sciences collection, _x2056-452X
500			_aAnimated audio-visual presentation with synchronized narration.
500			_aTitle from title frames.
505	0		_aContents: Cellular and gene therapy products -- U.S. laws and regulations -- FDA review -- Product development considerations -- Regulatory considerations -- Product manufacturing stages and quality testing -- Safety, efficacy and ethical considerations for clinical program design -- FDA Guidance documents.
506			_aAccess restricted to subscribers.
538			_aMode of access: World Wide Web.
610	1	0	_aUnited States _bFood and Drug Administration.
650		0	_aCellular therapy _xLaw and legislation.
650		0	_aCellular therapy _xMoral and ethical aspects.
650		0	_aGene therapy _xLaw and legislation.
650		0	_aGene therapy _xMoral and ethical aspects.
650		0	_aHuman genetics _xGovernment policy _zUnited States.
650		0	_aStem cells _xTherapeutic use.
650		2	_aCell- and Tissue-Based Therapy _xethics.
650		2	_aCell- and Tissue-Based Therapy _xstandards.
650		2	_aGenetic Therapy _xethics.
650		2	_aGenetic Therapy _xlegislation & jurisprudence.
650		2	_aGenetic Therapy _xstandards.
650		2	_aUnited States Food and Drug Administration.
830		0	_aHenry Stewart talks. _pBiomedical & life sciences collection.
856	4	0	_uhttps://hstalks.com/bs/4793/
999			_c75640 _d75640