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 ...
FDA warns Eagan, MN-based Bell International Laboratories about CGMP violations in its production of finished drugs.
FDA warns Dallas, TX-based Colgin, Inc., about CGMP violations in its production of finished drugs.
FDA warns Fresenius Kabi USA about QS and MDR issues at its North Andover, MA, facility that manufactures and distributes the Ivenix Infusion System.
