FDA releases summaries of two PDUFA 7 negotiating sessions by the FDA/industry pre-market subgroup.
FDA releases its latest batch of Warning Letters that includes one medical product company Hou Fu Biotech.
FDA clears a Zimmer Biomet 510(k) for the Rosa Partial Knee System for robotically-assisted partial knee replacement surgeries.
AdvaMed says FDA should apply the same policies to software in a medical device that it applies to software as a medical device.
FDA releases a summary of discussions on seven topics at the second MDUFA 5 reauthorization negotiation meeting.
A bipartisan group of House members introduces legislation to end mandatory animal testing in drug development.
FDA eases possible pooling of some Covid test nasal specimens in serial testing programs.
Officials of Y-mAbs Therapeutics say they are collecting additional omburtamab data sought by FDA to be able to agree on a statistical analysis plan.