FDA releases trial guidance on drug safety

In case it was lost in the excitement of the US midterms on Tuesday, the Food and Drug Administration (FDA) published some important draft guidance for drugmakers.

The FDA is consulting on a document called Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biologic Products.

This guidance provides assistance for companies that are making filings or supplemental applications on the appropriate use of prospective meta-analyses to assess a product risk.