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FDA Fast Track Development Program
Results: 173

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11	Breakthrough Therapy Program U.S. Food and Drug Administration (FDA) Presentation before the European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2015-02-13 09:30:33 Clinical research Health Pharmaceutical industry Epidemiology FDA Fast Track Development Program Clinical trial New Drug Application Imaging biomarker Pharmaceutical sciences Pharmacology Food and Drug Administration
12	THE 21ST CENTURY CURES DISCUSSION DOCUMENT It has been reported that among the 10,000 known diseases, 7,000 of which are considered rare, there are treatments for only 500. According to Dr. Francis Collins, Director of t Add to Reading List Source URL: energycommerce.house.gov Language: English - Date: 2015-01-27 15:26:58 Pharmacology Food and Drug Administration Pharmaceutical industry Medical statistics Clinical research MODDERN Cures Act Clinical trial FDA Fast Track Development Program Alternative medicine Pharmaceutical sciences Health Medicine
13	White Paper \| March[removed]Expedited Review Programs For Oncology Drugs From the FDA: Add to Reading List Source URL: www.wwctrials.com Language: English - Date: 2014-04-25 11:16:43 Research Pharmacology Epidemiology Clinical research Pharmaceutical industry FDA Fast Track Development Program New Drug Application Surrogate endpoint Prescription Drug User Fee Act Food and Drug Administration Medicine Health
14	Global Press Release Template Color logo August 2010 Add to Reading List Source URL: www.ibmmyositis.com Language: English - Date: 2013-11-03 00:53:06 FDA Fast Track Development Program Pharmaceutical industry Health Inclusion body myositis Novartis
15	Andrea Sloan CURE Act Section-by-Section SECTION 1. SHOT TITLE. The Andrea Sloan Compassionate Use Reform and Enhancement Act, or the Andrea Sloan CURE Act. SEC. 2. EXPANDED ACCESS POLICY AS CONDITION OF EXPEDITED APPROV Add to Reading List Source URL: mccaul.house.gov Language: English - Date: 2014-12-08 13:54:59 Research Clinical research Clinical pharmacology United States Public Health Service Expanded access Investigational New Drug FDA Fast Track Development Program Pharmaceutical industry Adverse event Pharmacology Pharmaceutical sciences Food and Drug Administration
16	(System Info[removed]SMITH MICHAEL[removed]:32:55 SMITHM) RECORD OF TELEPHONE CONVERSATION Submission Type: BLA Submission ID: [removed] Add to Reading List Source URL: www.fda.gov Language: English Biotechnology Pharmacology Center for Biologics Evaluation and Research Influenza FDA Fast Track Development Program Pfizer Wyeth Prescription Drug User Fee Act Jim Medicine Food and Drug Administration Health
17	Oncologic Drugs Advisory Committee (ODAC) Add to Reading List Source URL: www.fda.gov Language: English Medicine Purines Clinical pharmacology United States Public Health Service New Drug Application FDA Fast Track Development Program Cetuximab Clofarabine Nelarabine Food and Drug Administration Pharmacology Pharmaceutical sciences
18	Rare Pediatric Disease Priority Review Vouchers, Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: November 17, 2014 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Orphan drug Priority review voucher FDA Fast Track Development Program New Drug Application Orphan Drug Act Center for Biologics Evaluation and Research Prescription Drug User Fee Act Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
19	Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Add to Reading List Source URL: www.fda.gov Language: English Medical statistics Clinical trials Pharmacology Epidemiology Clinical endpoint End point of clinical trials Surrogate endpoint FDA Fast Track Development Program Food and Drug Administration Medicine Health Clinical research
20	Managing Risk and Uncertainty Through the Drug Life cycle Recent FDA Initiatives Theresa Mullin, PhD Director Add to Reading List Source URL: www.irgc.org Language: English - Date: 2014-10-27 11:06:55 Pharmacology Food and Drug Administration Clinical research Pharmaceutical industry Epidemiology Clinical trial Patient safety FDA Fast Track Development Program New Drug Application Medicine Health Pharmaceutical sciences

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