Newsletter | April 23, 2019

04.23.19 -- Regenerative Medicine & The 351 Vs. 361 Regulatory Framework


Good day Cell & Gene readers:


In recent months, the FDA has increased its compliance focus on the regenerative medicine industry, vowing to crack down on illicit stem cell clinics and others advertising the untested use of human cell and tissue-based products (HCT/P). Here’s a breakdown of the 351 vs. 361 regulatory framework.


Whether because of unfamiliarity or lack of resources, master service or supply agreement (MSA) execution can be time-consuming and difficult for cell and gene therapy companies. As such, here are three ways to save time when reviewing an MSA.


Erin Harris, editor in chief
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