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Health / Biologic License Application / Center for Biologics Evaluation and Research / Pharmaceutical industry / Regulatory requirement / Center for Drug Evaluation and Research / Abbreviated New Drug Application / Structured Product Labeling / Prescription Drug User Fee Act / Food and Drug Administration / Pharmaceutical sciences / Medicine


OMB INFORMATION COLLECTION SUPPORTING STATEMENT
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Document Date: 2005-10-06 10:05:35

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File Size: 105,50 KB

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USD / /

IndustryTerm

improved technology / few applications / biological products / allergenic products / electronic license applications / certain licensed biological products / electronic information systems technology / manufacturing change / supplemental applications / biological product / news services / particular product / certain biological products / license applications / licensed biological products / /

MedicalTreatment

antibiotics / plasmapheresis / /

Organization

Federal Government / Food and Drug Administration / FDA / office of Management and Budget / Center for Biologics Evaluation and Research / office of Communications / Training / and Manufacturers Assistance / Center for Drugs Evaluation and Research / using Form FDA / /

Position

medical director / OMB INFORMATION COLLECTION SUPPORTING STATEMENT General Licensing Provisions / regulatory affairs specialist / /

Technology

bar code / electronic information systems technology / Information Technology / antibodies / radiopharmaceuticals / /

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