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Clinical research / Brain tumor / Gadopentetic acid / Guerbet / FDA Special Protocol Assessment / Gadoteric acid / Clinical trial / Magnetic resonance imaging / Food and Drug Administration / Medicine / Pharmaceutical sciences / Pharmacology


[removed]Gadoterate Statistical PREA
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City

Reference / /

Company

AEs / Guerbet LLC / OTHER SPECIAL/SUBGROUP / ITT / /

Continent

Europe / /

Country

Germany / France / Austria / United States / Brazil / Italy / Korea / United Kingdom / Argentina / Spain / Chile / /

Event

FDA Phase / /

IndustryTerm

planned manufacturing sites / magnetic resonance imaging / imaging / /

MedicalCondition

renal insufficiency / spinal tumors / infectious diseases / renal failure / brain tumors / inflammatory / /

MedicalTreatment

surgery / /

Organization

U.S. Department of Health and Human Services / Translational Sciences Office / FOOD AND DRUG ADMINISTRATION / Team Leader Biometrics Division / Food and Drug Administration Center for Drug Evaluation / V Division of Medical Imaging Products / Research Office / Medical Division / /

Person

Magnevist / Thomas E. Gwise / Alex Gorovets / Max Weight / Dwaine Rieves / Satish Misra / D. James W Moore Keywords / Team / Barbara Stinson / Jyoti Zalkikar / /

Position

Deputy Director / Project Manager / /

Product

Magnevist / Design Drug / eCTD / France / DGD-3-44 / DGD-03-44 / DGD-44-050 / DGD-44-051 / indication / /

ProgrammingLanguage

L / R / C / /

Region

Latin America / /

Technology

magnetic resonance imaging / MRI / Medical Imaging / /

SocialTag