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 Pharmaceutical industry Pharmaceutics Food and Drug Administration Bioequivalence Pharmacokinetics Generic drug Abbreviated New Drug Application NIPTE Center for Drug Evaluation and Research Pharmaceutical sciences Pharmacology Pharmaceuticals policy |
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Generic Drug User Fee Amendments of 2012 Regulatory Science Initiatives: | CENTER FOR DRUG EVALUATION AND RESEARCH DRUG SAFETY PRIORITIES 2017DocID: 1ueGS - View Document |
| CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208573Orig1s000 SUMMARY REVIEWDocID: 1t19G - View Document |
| CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022526Orig1s000 SUMMARY REVIEWDocID: 1sZi5 - View Document |
| MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCHDocID: 1sPXO - View Document |
| Abstract # 2639 Enhanced (Q)SAR Models for Prediction Rodent Carcinogenicity Naomi L. Kruhlak1, Dongyu Guo1, Kevin P. Cross2, Lidiya Stavitskaya1 FDA Center for Drug Evaluation and Research (CDER), 10903 New Hampshire ADocID: 1swgc - View Document |