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FDA Fast Track Development Program
Results: 173

#	Item
121	FOOD AND DRUG ADMINISTRATION Add to Reading List Source URL: www.fda.gov Language: English Organic chemistry Organofluorides Amides Lactams Olaparib Piperazines Oncology Drug Advisory Committee Ovarian cancer FDA Fast Track Development Program Chemistry Food and Drug Administration Medicine
122	Predicting/Providing Substantial Evidence of Clinical Benefit for New Drug Approvals Albert Deisseroth, Division of Hematology Products February 27, 2013 Add to Reading List Source URL: www.fda.gov Language: English Research Viral load Surrogate endpoint HIV FDA Fast Track Development Program Clinical endpoint Food and Drug Administration Imaging biomarker Discovery and development of integrase inhibitors Medicine HIV/AIDS Health
123	Transcript: Public Workshop on Minimal Residual Disease (MRD) as a Surrogate Endpoint in Chronic Lymphocytic Leukemia (CLL) Add to Reading List Source URL: www.fda.gov Language: English Clinical trials Epidemiology Medical research Medical terms FDA Fast Track Development Program Surrogate endpoint Minimal residual disease B-cell chronic lymphocytic leukemia Center for Devices and Radiological Health Medicine Health Food and Drug Administration
124	Predicting/Providing Substantial Evidence of Clinical Benefit for New Drug Approvals Albert Deisseroth, Division of Hematology Products March 4, 2013 Add to Reading List Source URL: www.fda.gov Language: English Research Viral load Surrogate endpoint HIV FDA Fast Track Development Program Clinical endpoint Food and Drug Administration Imaging biomarker Discovery and development of integrase inhibitors Medicine HIV/AIDS Health
125	Regulatory Basis for U.S. Drug & Biologics Approval Paul G. Kluetz, M.D. Office of Hematology and Oncology Products 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 FDA Fast Track Development Program Clinical trial Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
126	Federal Register / Vol. 78, No[removed]Tuesday, January 15, [removed]Notices[removed]TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Recognition Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2013-01-15 02:59:43 Medicine FDA Fast Track Development Program Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Clinical trial New Drug Application Food and Drug Administration Health Pharmaceutical sciences
127	[removed]Federal Register / Vol. 77, No[removed]Wednesday, May 30, [removed]Notices of the information collection. Email address: [removed]. Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2013-05-23 12:20:55 Clinical pharmacology Ribbon symbolism FDA Fast Track Development Program Food and Drug Administration Breast cancer Drug discovery Pharmaceutical sciences Pharmacology Medicinal chemistry
128	[removed]Federal Register / Vol. 76, No[removed]Thursday, August 4, [removed]Notices order approving, denying, or withdrawing approval of a PMA will continue to include a notice of Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2013-05-23 12:43:39 Pharmacology Health Research Clinical research Drug discovery New Drug Application FDA Fast Track Development Program Drug development Center for Devices and Radiological Health Food and Drug Administration Pharmaceutical sciences Pharmaceutical industry
129	Public Workshop on Complex Issues in Developing Drug and Biological Products for Rare Diseases Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceuticals policy Health Prescription Drug User Fee Act FDA Fast Track Development Program Rare disease ClinicalTrials.gov Food and Drug Administration Pharmaceutical sciences Clinical research
130	Priorities for CDER[removed] Add to Reading List Source URL: www.fda.gov Language: English Clinical research Medicinal chemistry Prescription Drug User Fee Act FDA Fast Track Development Program Biologic Center for Drug Evaluation and Research Drug development Food and Drug Administration Pharmacology Pharmaceutical sciences

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