We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Lays Out Proposed Ground Rules for Natural History Studies
FDA Lays Out Proposed Ground Rules for Natural History Studies
Drug sponsors who want to use natural histories to help develop treatments for rare diseases should draw up well-defined statistical analysis plans and probably even hire statisticians to help develop the histories, the FDA said in new draft guidance issued Friday.