WASHINGTON – The US Food and Drug Administration's (FDA) Jill Furman, director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance (OC), reported that there has been a 50% ...

Add Yahoo as a preferred source to see more of our stories on Google. Tracy Beth Hoeg has been appointed as the FDA's new CDER lead The US Food and Drug Administration (FDA) has selected Tracy Beth ...

A now-deleted LinkedIn post from a top FDA official has raised the hackles of Aurinia Pharmaceuticals as industry watchers puzzle over the official's decision to target the approvability of surrogate ...

In comments to US Food and Drug Administration (FDA) February draft guidance, industry experts called on the agency for alignment of the approaches to voluntary consensus standards (VCS) recognition.