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...
FDA grants Quanterix a breakthrough device designation for its Simoa phospho-Tau 217 blood test as an aid in diagnostically evaluating Alzheimers Dise...
Federal Register notice: FDA makes available its decision to deny a request for a hearing on a CDER-proposed decision to not approve a Vanda Pharmaceu...
Federal Register notice: FDA sends to OMB an information collection revision entitled Applications for FDA Approval To Market a New Drug 21 CFR Part ...
