Definition

FDA programme to manage serious risks of a drug; may include ETASU (elements to assure safe use), communication plan, and implementation system.

Example

REMS with restricted distribution and pregnancy testing for a teratogen.

Regulatory source

FDA FDAAA, 21 CFR Part 208

Common mistakes

Treating REMS as optional or not tracking compliance metrics.

Inspector question

How do you ensure REMS compliance and document effectiveness?

Related terms