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Medical Devices

Ventec Life Recalls VOCSN Breathing Package

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...

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Human Drugs

ICH Analytical Procedure Development Guidance

FDA publishes the ICH Q14 guidance on analytical procedure development.

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Use Healthcare AI for Patients First: Califf

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

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Human Drugs

ICH Analytical Procedure Validation Guidance

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

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Human Drugs

Pfizers Besponsa Expanded Use in Pediatric Leukemia

FDA approves Pfizers Besponsa (inotuzumab ozogamicin) for an expanded indication treating pediatric patients with relapsed or refractory CD22-positiv...

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Human Drugs

MIDD Pilot Lessons Learned

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

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Human Drugs

Lantheus sNDA Approved for Definity Pediatric Use

FDA approves a Lantheus Holdings supplemental NDA for an expanded use for ultrasound enhancing agent Definity (perflutren lipid microsphere) in pediat...

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Medical Devices

Quanterix Gets Breakthrough Status for Alzheimers Test

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

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Federal Register

FDA Decision Denying Vanda sNDA Hearing

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...

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Federal Register

Info Collection Revision on NDA Form

Federal Register notice: FDA sends to OMB an information collection revision entitled Applications for FDA Approval To Market a New Drug 21 CFR Part ...