Analyses of cell and gene therapy development: what the Agency expects, where programs stall between the laboratory and the clinic, and how the decisions that determine a program's course are made in practice.
INTERACT is the earliest formal mechanism through which a sponsor may engage CBER on a novel product. The briefing document determines whether that engagement is granted and whether its outcome can be acted upon.
Articles cite FDA CBER guidance, ICH guidelines, and the Code of Federal Regulations. The Regulatory resources page indexes those sources by development stage, with links to the Agency's and ICH's own pages.
Most engagements begin with a short call to establish where the program stands and which decision comes next, whether it concerns regulatory strategy, manufacturing, nonclinical development, clinical readiness, intellectual property, or the disposition of a portfolio.