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ICH Analytical Procedure Development Guidance

[ Price : $8.95]

FDA publishes the ICH Q14 guidance on analytical procedure development.

Use Healthcare AI for Patients First: Califf

[ Price : $8.95]

FDA commissioner Robert Califf expresses fears that healthcare artificial intelligence will be used by health systems to make fina...

ICH Analytical Procedure Validation Guidance

[ Price : $8.95]

FDA publishes the ICH Q2(R2) guidance on validating analytical procedures.

Pfizers Besponsa Expanded Use in Pediatric Leukemia

[ Price : $8.95]

FDA approves Pfizers Besponsa (inotuzumab ozogamicin) for an expanded indication treating pediatric patients with relapsed or ref...

MIDD Pilot Lessons Learned

[ Price : $8.95]

CDER researchers describe lessons learned from the four-year Model-Informed Drug Development pilot program and plans for the progr...

Lantheus sNDA Approved for Definity Pediatric Use

[ Price : $8.95]

FDA approves a Lantheus Holdings supplemental NDA for an expanded use for ultrasound enhancing agent Definity (perflutren lipid mi...

Quanterix Gets Breakthrough Status for Alzheimers Test

[ Price : $8.95]

FDA grants Quanterix a breakthrough device designation for its Simoa phospho-Tau 217 blood test as an aid in diagnostically evalua...

FDA Decision Denying Vanda sNDA Hearing

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Federal Register notice: FDA makes available its decision to deny a request for a hearing on a CDER-proposed decision to not appro...

Info Collection Revision on NDA Form

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Applications for FDA Approval To Market a Ne...

Medfusion Syringe Pump Recalled Over Software

[ Price : $8.95]

Smiths Medical ASD recalls its Medfusion model 3500 syringe pump due to software-related issues that can cause the device to fail ...