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2 ICH Analytical Procedure Guides Available

[ Price : $8.95]

Federal Register notice: FDA makes available two International Council for Harmonization final guidances entitled Q2(R2) Validatio...

Gastrointestinal Drugs Committee Renewal

[ Price : $8.95]

Federal Register notice: FDA renews its Gastrointestinal Drugs Advisory Committee for an additional two years beyond the charter e...

Ventec Life Recalls VOCSN Breathing Package

[ Price : $8.95]

Ventec Life Systems recalls its VOCSN Patient Breathing Package due to a manufacturing issue that causes the bonded spiral wrap to...

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

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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...