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FDA Fast Track Development Program
Results: 173

#	Item
91	[removed]Federal Register / Vol. 69, No[removed]Monday, March 15, [removed]Notices application for ZELNORM (U.S. Patent No. 5,510,353) from Novartis Add to Reading List Source URL: www.fda.gov Language: English - Date: 2004-03-15 06:59:10 Pharmaceutical sciences Research Clinical research Pharmacology United States Public Health Service New Drug Application FDA Fast Track Development Program Investigational New Drug Food and Drug Administration Drug safety Medicine
92	August 26, 2013 Division of Dockets Management (HFA-305) US Food and Drug Administration 5630 Fishers Lane, Rm[removed]Rockville, MD[removed]Re: Docket No. FDA-2013-D-0575 Add to Reading List Source URL: www.rarediseases.org Language: English - Date: 2013-08-27 14:08:50 Health Clinical research Drug discovery Epidemiology Pharmaceuticals policy FDA Fast Track Development Program Orphan drug Rare disease Clinical trial Pharmaceutical sciences Food and Drug Administration Pharmacology
93	Report on the Second Review of the Backlog of Postmarketing Requirements and Commitments by the Add to Reading List Source URL: www.fda.gov Language: English Health Medicine Drug discovery Pharmaceutical industry United States Public Health Service Preventive Maintenance Checks and Services Clinical trial Center for Biologics Evaluation and Research FDA Fast Track Development Program Food and Drug Administration Pharmaceutical sciences Pharmacology
94	Final Report on the PMR/PMC Backlog Review Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Clinical pharmacology Therapeutics United States Public Health Service Preventive Maintenance Checks and Services MAG Prescription Drug User Fee Act FDA Fast Track Development Program PMRS Food and Drug Administration Pharmaceutical sciences Clinical research
95	1st draft of Colon Cancer Workshop Agenda (to begin the discussion) Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Clinical research Medical statistics Epidemiology FDA Fast Track Development Program Clinical trial Oxaliplatin Bevacizumab Nancy Fern Olivieri Chemistry Food and Drug Administration Pharmacology
96	Regulatory Background Edwin Rock, MD, PhD Medical Officer Office of Oncology Drug Products Food and Drug Administration Add to Reading List Source URL: www.fda.gov Language: English Research Clinical trials Clinical research Medical statistics Medical research Surrogate endpoint FDA Fast Track Development Program Randomized controlled trial Clinical endpoint Epidemiology Medicine Health
97	Federal Register / Vol. 72, No[removed]Friday, February 2, [removed]Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Report on the Performance of Drug and Biologics Firms in Conducting Add to Reading List Source URL: www.fda.gov Language: English - Date: 2007-02-02 07:48:46 Research Center for Biologics Evaluation and Research New Drug Application FDA Fast Track Development Program Center for Drug Evaluation and Research Food and Drug Administration Medicine Pharmaceutical sciences
98	Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics U.S. Department of Health and Human Services Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceutical sciences Health Clinical research Pharmaceutical industry Drug safety FDA Fast Track Development Program New Drug Application Expanded access Clinical trial Food and Drug Administration Pharmacology Medicine
99	Federal Register / Vol. 70, No[removed]Friday, February 18, [removed]Notices The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR[removed]The draft guidance, when finalized, Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-02-18 08:37:40 Medicine Center for Biologics Evaluation and Research Center for Drug Evaluation and Research New Drug Application FDA Fast Track Development Program Approved drug Adverse Event Reporting System Food and Drug Administration Research Pharmaceutical sciences
100	Microsoft Word[removed]2R.doc Add to Reading List Source URL: www.fda.gov Language: English Clinical research Abbreviated New Drug Application Prescription Drug User Fee Act Clinical trial FDA Fast Track Development Program Center for Drug Evaluation and Research Food and Drug Administration Pharmaceutical sciences Health

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