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New Drug Application
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#	Item
1	Morphochem’s Investigational New Drug (IND) application accepted by FDA – Novel antibacterial for IV treatment of CDI ready to move to Phase 2 Munich (Germany), June 22, 2016 — Morphochem, a clinical-stage pharmace Add to Reading List Source URL: www.morphochem.de Language: English - Date: 2016-07-05 04:16:59
2	Emergency Use: means the use of a test article on a human subject in a life-threatening situation in Add to Reading List Source URL: humansubjects.stanford.edu Language: English - Date: 2016-04-12 01:21:50 Medical research Health Food and Drug Administration Pharmaceutical industry Drug safety Clinical pharmacology Expanded access Clinical trial Investigational New Drug Informed consent New drug application Health Insurance Portability and Accountability Act
3	United States Government Accountability Office GAO Report to the Ranking Member, Committee on Finance, U.S. Senate Add to Reading List Source URL: www.gao.gov Language: English - Date: 2009-10-26 10:18:38 Health Food and Drug Administration Medicine Pharmaceutical industry Epidemiology Medical statistics Clinical trials Accelerated approval Surrogate endpoint New drug application Bevacizumab Fast track
4	Microsoft Word - FINAL 10K2014-Cover Page final to print Add to Reading List Source URL: www.casipharmaceuticals.com Language: English - Date: 2015-04-17 14:04:48 Medical research Health Pharmaceutical industry Clinical research Drug discovery Food and Drug Administration Design of experiments Drug development Phases of clinical research Clinical trial New drug application Spectrum Pharmaceuticals
5	Clark Transfer, Inc. Owner-Operator Application IMPORTANT NOTICE REGARDING BACKGROUND REPORTS Add to Reading List Source URL: clarktransfer.com Language: English - Date: 2013-07-01 12:35:21 Technology Road safety Digital media Transport Trucking industry in the United States Mobile phone New media Telephony Background check Drug test Federal Motor Carrier Safety Administration
6	Microsoft Worddoc Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Health Medical research Pharmaceutical industry Drug safety Clinical research Investigational New Drug Treatment IND Center for Drug Evaluation and Research Drug development Expanded access New drug application
7	Investigator Responsibilities in Protecting Participants in the Conduct of Bioequivalence Studies Cecilia C. Maramba, MD, MScID Add to Reading List Source URL: www.fercap-sidcer.org Language: English - Date: 2010-02-19 02:38:05 Pharmacokinetics Pharmaceutical industry Clinical research Bioequivalence Generic drug Bioavailability Food and Drug Administration Clinical trial Pharmaceutical drug Abbreviated New Drug Application
8	PUBLIC LAW 105–115—NOV. 21, 1997 FOOD AND DRUG ADMINISTRATION MODERIZATION ACT OF 1997 111 STAT. 2296 Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2012-03-21 10:56:20 Food and Drug Administration Pharmaceuticals policy Healthcare quality Prescription Drug User Fee Act Federal Food Drug and Cosmetic Act Abbreviated New Drug Application Compounding United States Code Controlled Substances Penalties Amendments Act Industrial Hemp Farming Act
9	Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmaceutical industry Pharmaceuticals policy Food law Abbreviated New Drug Application New drug application Federal Food Drug and Cosmetic Act Generic drug Approved Drug Products with Therapeutic Equivalence Evaluations Center for Drug Evaluation and Research Drug Master File
10	NEWS RELEASE EGEE SPEEDS UP HUNT FOR NEW MALARIA DRUGS The Drug Discovery application running on the Enabling Grids for E-sciencE (EGEE) production service aims to find potential new drugs to combat malaria, a disease wh Add to Reading List Source URL: grid.ucy.ac.cy Language: English - Date: 2007-03-06 04:27:04 Drug discovery Medicinal chemistry Cyberinfrastructure European Grid Infrastructure Grid computing Docking In silico Drug design Drug resistance