USA – HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules
The US Department of Health and Human Services (HHS) on Tuesday published a list of regulations its agencies will prioritize over the coming year....
USA – FDA draft guidance aims to help sponsors develop drugs for radiation exposure
The US Food and Drug Administration (FDA) on 19 April issued draft guidance that encourages sponsors to have “early and ongoing” communication with the...
USA – FDA finalizes guidances on RWD in regulatory submissions, assessing registries
The US Food and Drug Administration (FDA) on Thursday finalized two guidances that detail how sponsors can leverage and submit real-world data (RWD) in...
