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Proceedings: international regulatory considerations on development pathways for cell therapies.

Feigal EG, Tsokas K, Viswanathan S, Zhang J, Priest C, Pearce J, Mount N.

Stem Cells Transl Med. 2014 Aug;3(8):879-87. doi: 10.5966/sctm.2014-0122. Epub 2014 Jul 18.


Perspective: communications with the Food and Drug Administration on the development pathway for a cell-based therapy: why, what, when, and how?

Feigal EG, Tsokas K, Zhang J, Cromer MV, Whittlesey KJ, Werner MJ.

Stem Cells Transl Med. 2012 Nov;1(11):825-32. doi: 10.5966/sctm.2012-0104. Epub 2012 Oct 17.

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