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FDA Fast Track Development Program
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61	Volume 11, Number 8 August 2014 News and Strategies for Managing High-Cost Specialty Products Add to Reading List Source URL: aishealth.com Language: English - Date: 2014-08-15 14:40:44 Biosimilar Hospira Food and Drug Administration Biologic Clinical pharmacy Pharming Pharmaceutical industry FDA Fast Track Development Program Clinical trial Pharmacology Pharmaceutical sciences Clinical research
62	Report: Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases Add to Reading List Source URL: www.fda.gov. Language: English Health Clinical research Pharmaceuticals policy Pharmaceutical industry Prescription Drug User Fee Act European Medicines Agency FDA Fast Track Development Program Biologic Clinical trial Food and Drug Administration Pharmaceutical sciences Pharmacology
63	Breakthrough Therapies: Leveraging Best Practices from Expedited Reviews AAPS Annual Meeting San Antonio, Texas November 11, 2013 Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmaceutical industry Clinical pharmacology Pharmaceuticals policy FDA Fast Track Development Program Center for Drug Evaluation and Research Drug development Medical device Generic drug Pharmaceutical sciences Medicine Pharmacology
64	End Points and United States Food and Drug Administration Approval of Oncology Drugs By John R. Johnson, Grant Williams, and Richard Pazdur Purpose: To summarize the end points used by the United States Food and Drug Adm Add to Reading List Source URL: www.fda.gov Language: English Prostate cancer Breast cancer Radiation therapy Oncology FDA Fast Track Development Program Food and Drug Administration Oxaliplatin Metastatic breast cancer Glioblastoma multiforme Medicine Ribbon symbolism Radiation oncology
65	U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may Add to Reading List Source URL: www.fda.gov Language: English Research Clinical trials Medical statistics Medical research Medical terms FDA Fast Track Development Program Surrogate endpoint Randomized controlled trial Food and Drug Administration Medicine Health Epidemiology
66	Project FDA Report No. 6 May 2013 The Digital Future of Molecular Medicine: Rethinking FDA Regulation Add to Reading List Source URL: www.manhattan-institute.org Language: English - Date: 2013-05-14 16:39:39 Health Food and Drug Administration Drug discovery Pharmaceutical industry Pharmaceuticals policy Pharmacovigilance FDA Fast Track Development Program Clinical trial Prescription Drug User Fee Act Pharmaceutical sciences Pharmacology Medicine
67	Regulatory Background: Ovarian Cancer Clinical Endpoints Add to Reading List Source URL: www.fda.gov Language: English Clinical trials Epidemiology Medical research Medical terms Medical statistics Surrogate endpoint FDA Fast Track Development Program Clinical endpoint Food and Drug Administration Medicine Health Research
68	FDA Approvals in Multiple Myelomar Add to Reading List Source URL: www.fda.gov Language: English Clinical trials Food and Drug Administration Medical terms Medical statistics Medical research FDA Fast Track Development Program Surrogate endpoint End point of clinical trials Progression-free survival Medicine Health Clinical research
69	1st draft of Colon Cancer Workshop Agenda (to begin the discussion) Add to Reading List Source URL: www.fda.gov Language: English Cancer FDA Fast Track Development Program Medicine Adjuvant therapy Colorectal cancer
70	Clinical Benefit for New Drug Approvals Albert Deisseroth, M.D., Ph.D. Division of Hematology Products (DHP) Office of Hematology and Oncology Products (OHOP) Office of New Drugs (OND), CDER, FDA Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Clinical research Viral load Virology HIV FDA Fast Track Development Program Surrogate endpoint HIV test Index of AIDS-related articles HIV/AIDS Medicine Health

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