Federal Register notice: FDA renews its Gastrointestinal Drugs Advisory Committee for an additional two years beyond the charter expiration date.
Ventec Life Systems recalls its VOCSN Patient Breathing Package due to a manufacturing issue that causes the bonded spiral wrap to detach before or du...
FDA publishes the ICH Q14 guidance on analytical procedure development.
FDA commissioner Robert Califf expresses fears that healthcare artificial intelligence will be used by health systems to make financial decisions rath...
FDA publishes the ICH Q2(R2) guidance on validating analytical procedures.
FDA approves Pfizers Besponsa (inotuzumab ozogamicin) for an expanded indication treating pediatric patients with relapsed or refractory CD22-positiv...
CDER researchers describe lessons learned from the four-year Model-Informed Drug Development pilot program and plans for the programs future.
FDA approves a Lantheus Holdings supplemental NDA for an expanded use for ultrasound enhancing agent Definity (perflutren lipid microsphere) in pediat...