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FDA Fast Track Development Program
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1	White Paper Consulting Services Supporting Over 50 New Drug Approvals, Labels, and Submissions through Biosimulation Add to Reading List Source URL: www.certara.com Language: English - Date: 2014-12-30 11:01:08 Medicine Drug discovery Pharmaceutical industry Clinical research Clinical trial FDA Fast Track Development Program Orphan drug Drug development Paracetamol Pharmaceutical sciences Pharmacology Food and Drug Administration
2	21ST CENTURY CURES DISCUSSION DRAFT Energy and Commerce Committee Chairman Fred Upton (R-MI), Rep. Diana DeGette (D-CO), Health Subcommittee Chairman Joe Pitts (R-PA), Ranking Member Frank Pallone (D-NJ), and Health Subc Add to Reading List Source URL: energycommerce.house.gov Language: English - Date: 2015-04-29 12:05:31 Food and Drug Administration Pharmacology Pharmaceutical industry Clinical research National Institutes of Health ClinicalTrials.gov New Drug Application Clinical trial FDA Fast Track Development Program Medicine Health Research
3	21ST CENTURY CURES DISCUSSION DRAFT TITLE I - DISCOVERY SUBTITLE A- NATIONAL INSTITUTES OF HEALTH FUNDING SECTION 1001 – NATIONAL INSTITUTES OF HEALTH REAUTHORIZATION This section would reauthorize the National Institu Add to Reading List Source URL: energycommerce.house.gov Language: English - Date: 2015-05-13 10:21:22 Food and Drug Administration Pharmacology Pharmaceutical industry Clinical research National Institutes of Health ClinicalTrials.gov New Drug Application FDA Fast Track Development Program Clinical trial Medicine Health Research
4	Welcome to the STI - SCIH Newsletter! Target patient enrollment number in Phase III Trial of Pafuramidine Maleate (DB289) in Treatment of Sleeping Sickness reached We are very pleased to announce that the targ Add to Reading List Source URL: www.swisstph.ch Language: English - Date: 2013-09-12 05:44:27 Chemistry Food and Drug Administration Pafuramidine furans Clinical research African trypanosomiasis Pentamidine Clinical trial FDA Fast Track Development Program Amidines Medicine Health
5	Dear (Name of your Congressional and Senatorial Official at the Federal Level), I am writing to express interest in the approval status of a bio-drug produced by Genervon Biopharmaceuticals LLS, known as GM604 or GM6 Add to Reading List Source URL: www.every90minutes.org Language: English - Date: 2015-01-15 13:15:12 Food and Drug Administration Pharmacology Pharmaceutical industry Pharmaceuticals policy FDA Fast Track Development Program Approved drug Amyotrophic lateral sclerosis Orphan drug Riluzole Pharmaceutical sciences Health Clinical research
6	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: www.cohealthcom.org Language: English - Date: 2015-01-29 13:30:12 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
7	Fact sheet 28 March, 2014 China Hong Kong Add to Reading List Source URL: www.jpma.or.jp Language: English - Date: 2014-06-26 21:25:06 Research Pharmacology Drug safety Food and Drug Administration Electronic Common Technical Document New Drug Application Drug Master File Quality by Design FDA Fast Track Development Program Pharmaceutical sciences Pharmaceutical industry Clinical research
8	FOOD & DRUG ADMINISTRATIONPRIVATE + + + + + Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmaceutical industry Clinical research Drug discovery Clinical trial Orphan drug FDA Fast Track Development Program Adverse event Drug development Pharmaceutical sciences Pharmacology Health
9	Task B Proposal Document APAC RA-EWG Task B Convergence of NDA Requirements Add to Reading List Source URL: www.jpma.or.jp Language: English - Date: 2014-06-26 21:25:06 Clinical research Food and Drug Administration Drug discovery Clinical trial FDA Fast Track Development Program Drug Master File Regulatory requirement Drug development Pharmaceutical sciences Pharmacology Pharmaceutical industry
10	Patient‐Focused Drug Development Public Meeting Public Meeting Theresa M. Mullin, Ph.D. Associate Director for Planning and Informatics FDA Center for Drug Evaluation and Research Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmacology Pharmaceuticals policy Prescription Drug User Fee Act FDA Fast Track Development Program Fibromyalgia Food and Drug Administration Health Pharmaceutical sciences

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