Posted on 26 Jan 2018

News of interest to medical writers: FDA joins the global push towards publication of trial data through CSRs

The FDA has announced plans to publish CSRs in a pilot scheme “…to evaluate whether disclosing certain information included within CSRs following approval of a NDA improves public access to drug approval information.”

The plans indicate that the CSR body, protocol and statistical analysis plan will be shared. When the pilot is concluded, public feedback will be sought.

We will keep you informed of further developments.