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Pharmaceutical sciences / Center for Biologics Evaluation and Research / New Drug Application / Regulatory requirement / Biologic License Application / Center for Drug Evaluation and Research / Title 21 of the Code of Federal Regulations / Biologic / Prescription Drug User Fee Act / Food and Drug Administration / Medicine / Health


OMB INFORMATION COLLECTION SUPPORTING STATEMENT New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy S
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Document Date: 2000-01-07 07:23:47

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File Size: 21,88 KB

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improved technology / biological products / electronic information systems technology / software approaches / pharmaceutical sponsors / electronic biologics license applications / analytical tools / supplemental applications / biological product / chemical / license applications / /

Organization

Federal Government / Food and Drug Administration / office of Training and Communications / office of Communication / Training / and Manufacturer / Public Health Service / Center for Drug Evaluation and Research / Center for Biologics Evaluation and Research / /

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level manager / General / manager / mid-level professional / /

Technology

electronic information systems technology / Information Technology / pharmacodynamics / /

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