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Pendetide / Indium (111In) capromab pendetide / Prostate-specific antigen / Radiation therapy / Food and Drug Administration / Medical imaging / Metastasis / Medicine / Medical physics / Prostate cancer


ProstaScint Kit Untitled Letter
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City

Beltsville / Reference / /

Company

Regulatory Affairs EUSA Pharma (USA) Inc. / ProstaScint / Ph.D. EUSA Pharma (USA) Inc. / EUSA Pharma (USA) Inc. / Regulatory Affairs EUSA Pharma / /

Event

FDA Phase / Product Issues / /

Facility

Inc. One Summit Square / /

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IndustryTerm

hour imaging session / patient management / diagnostic imaging agent / imaging / /

MedicalCondition

biopsy-proven prostate cancer / hypertension / Cancer / occult metastatic disease / pelvic lymph node metastases / anaphylaxis / carcinoma / increased prostate cancer / metastatic disease / allergic reactions / hypersensitivity / clinically-localized prostate cancer / prostate cancer / residual prostate cancer / metastases / hypotension / /

MedicalTreatment

radiation therapy / prostatectomy / enema / surgery / radiation / /

Organization

Division of Direct-to-Consumer Promotion / Food and Drug Administration / Division of Professional Promotion / Division of Drug Marketing / Advertising / and Communications / office of Prescription Drug Promotion / Center for Drug Evaluation and Research / DEPARTMENT OF HEALTH / Professional Promotion Office / /

Person

JAMES S DVORSKY / Silver Spring / James S. Dvorsky / Nadler / /

Position

Director / PharmD Regulatory Review Officer Division / /

Product

digoxin / ProstaScint / Indium / Communication / Prescription Drug / /

ProvinceOrState

Pennsylvania / Maryland / /

Technology

radiation / diagnostic imaging / x-ray / Tomography / antibodies / MRI / /

SocialTag