PSUR as support for safety claims
is it possible to use a PSUR as support for a safety claim (incidence of AE's)?
Jennifer Carroll last edited by
No. Code section 3.1.1 states: Clinical or therapeutic claims must be based on published, peer-reviewed, controlled, and well-designed studies with clinical and statistical significance clearly indicated. Review articles, pooled data, meta-analysis, post-hoc analysis, and observational studies are generally regarded as not being evidence to support claims in drug advertising. Data included in the TMA may be acceptable.