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Magnetic resonance imaging / Gadodiamide / Medical imaging / Gadopentetic acid / Nephrogenic systemic fibrosis / Gadoteridol / Gadolinium / Chemistry / Medicine / Matter


[removed]Gadobutrol Statistical PREA
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City

Reference / /

Company

Bayer / SPECIAL/SUBGROUP / James Moore Pharm / OTHER SPECIAL/SUBGROUP / /

Continent

Asia / South America / /

Country

Germany / Japan / United States / China / South Korea / /

Event

FDA Phase / Product Recall / Product Issues / /

IndustryTerm

gadolinium products / imaging / /

MedicalCondition

serious disease / systemic fibrosis / fibrosis / /

Organization

U.S. Department of Health and Human Services / Standard Biometrics Division / Translational Sciences Office / National Science Foundation / FDA / Food and Drug Administration Center for Drug Evaluation / Research Office / Advisory Committee / /

Person

Lucie Yang / Rafel Rieves / Barbara Stinson / /

Position

investigator / Clinical Division Director / Division Director / Project Manager / Acting Team Leader / /

Product

Omniscan / Optimark / Magnevist / No Dosing / ProHance / Multihance / NDA201277 / Study310124 / CNS / CNS Imaging / Study310123 / /

Region

Eastern Europe / /

Technology

neuroscience / scoring protocol / Imaging Protocol / MRI / Medical Imaging / /

SocialTag