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FDA publishes the ICH Q14 guidance on analytical procedure development.[ Price : $8.95]
FDA commissioner Robert Califf expresses fears that healthcare artificial intelligence will be used by health systems to make fina...[ Price : $8.95]
FDA publishes the ICH Q2(R2) guidance on validating analytical procedures.[ Price : $8.95]
FDA approves Pfizers Besponsa (inotuzumab ozogamicin) for an expanded indication treating pediatric patients with relapsed or ref...[ Price : $8.95]
CDER researchers describe lessons learned from the four-year Model-Informed Drug Development pilot program and plans for the progr...[ Price : $8.95]
FDA approves a Lantheus Holdings supplemental NDA for an expanded use for ultrasound enhancing agent Definity (perflutren lipid mi...[ Price : $8.95]
FDA grants Quanterix a breakthrough device designation for its Simoa phospho-Tau 217 blood test as an aid in diagnostically evalua...[ Price : $8.95]
Federal Register notice: FDA makes available its decision to deny a request for a hearing on a CDER-proposed decision to not appro...