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FDA Fast Track Development Program
Results: 173

#	Item
101	Report on the Review of the Backlog of Postmarketing Requirements and Commitments by FDA 2010 Add to Reading List Source URL: www.fda.gov Language: English Medicine Center for Biologics Evaluation and Research FDA Fast Track Development Program Center for Drug Evaluation and Research Preventive Maintenance Checks and Services Clinical trial Food and Drug Administration Pharmaceutical sciences Health
102	[removed]Federal Register / Vol. 71, No[removed]Friday, March 3, [removed]Notices wwhite on PROD1PC61 with NOTICES Add to Reading List Source URL: www.fda.gov Language: English - Date: 2006-03-03 08:14:24 Research Center for Biologics Evaluation and Research New Drug Application Center for Drug Evaluation and Research FDA Fast Track Development Program Food and Drug Administration Medicine Pharmaceutical sciences
103	Federal Register / Vol. 73, No[removed]Thursday, April 24, [removed]Notices • Other issues and questions raised by the workshop attendees or others. C. Is There a Fee and How Do I Register for the Workshop? There is a mode Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2010-12-01 22:36:32 Research Center for Biologics Evaluation and Research New Drug Application Center for Drug Evaluation and Research FDA Fast Track Development Program Food and Drug Administration Medicine Pharmaceutical sciences
104	pmangrum on DSK3VPTVN1PROD with NOTICES Federal Register / Vol. 77, No[removed]Tuesday, March 6, [removed]Notices where American Indian and Alaska Native (AI/AN) programs are located. We are convening the OHS Tribal Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2013-05-23 12:56:25 Pharmaceutical sciences Research Pharmacology Drug safety New Drug Application Clinical trial Investigational Device Exemption FDA Fast Track Development Program Food and Drug Administration Pharmaceutical industry Clinical research
105	GAO[removed], Prescription Drugs: FDA Has Met Most Performance Goals for Reviewing Applications Add to Reading List Source URL: www.gao.gov Language: English - Date: 2012-04-30 12:50:08 Health Pharmacology Pharmaceutical industry Prescription Drug User Fee Act Food law New Drug Application FDA Fast Track Development Program Generic drug Center for Drug Evaluation and Research Food and Drug Administration Pharmaceutical sciences Pharmaceuticals policy
106	Considerations for Neoadjuvant Breast Cancer Trials to Support Accelerated Approval Add to Reading List Source URL: www.fda.gov Language: English Biology Trastuzumab Breast cancer HER2/neu FDA Fast Track Development Program Food and Drug Administration Breast cancer treatment MammaPrint Medicine Chemistry Ribbon symbolism
107	New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals As of December 31, 2012 Selection Criteria: User Response: Start Date: [removed]End Date: [removed] Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Piperazines Eli Lilly and Company New Drug Application Pharmaceutical industry Tapentadol Levofloxacin Ofloxacin FDA Fast Track Development Program Chemistry Pharmacology Organic chemistry
108	Regulatory Basis for U.S. Drug & Biologics Approval Paul G. Kluetz, M.D. Office of Hematology and Oncology Products 1 Add to Reading List Source URL: www.fda.gov Language: English Clinical research Center for Devices and Radiological Health Center for Drug Evaluation and Research Biologic Center for Biologics Evaluation and Research Surrogate endpoint Clinical trial FDA Fast Track Development Program Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
109	DrugApprovalProcess_Infographic_vertical_full Add to Reading List Source URL: www.fda.gov Language: English Medicine Prescription Drug User Fee Act New Drug Application FDA Fast Track Development Program Investigational New Drug Center for Drug Evaluation and Research Pharmaceutical industry MedWatch Clinical trial Food and Drug Administration Pharmaceutical sciences Health
110	U.S. Food and Drug Administration What is a drug as defined by the FDA? Drug Approval Process Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Medicine Clinical research Pharmaceutical industry Drug safety New Drug Application Prescription Drug User Fee Act FDA Fast Track Development Program Investigational New Drug Food and Drug Administration Pharmaceutical sciences Health

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