New Drug Application

Results: 3686



#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

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Source URL: www.morphochem.de

Language: English - Date: 2016-07-05 04:16:59
    2Medical 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

    Emergency Use: means the use of a test article on a human subject in a life-threatening situation in

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    Source URL: humansubjects.stanford.edu

    Language: English - Date: 2016-04-12 01:21:50
    3Health / Food and Drug Administration / Medicine / Pharmaceutical industry / Epidemiology / Medical statistics / Clinical trials / Accelerated approval / Surrogate endpoint / New drug application / Bevacizumab / Fast track

    United States Government Accountability Office GAO Report to the Ranking Member, Committee on Finance, U.S. Senate

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    Source URL: www.gao.gov

    Language: English - Date: 2009-10-26 10:18:38
    4Medical 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

    Microsoft Word - FINAL 10K2014-Cover Page final to print

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    Source URL: www.casipharmaceuticals.com

    Language: English - Date: 2015-04-17 14:04:48
    5Technology / 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

    Clark Transfer, Inc. Owner-Operator Application IMPORTANT NOTICE REGARDING BACKGROUND REPORTS

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    Source URL: clarktransfer.com

    Language: English - Date: 2013-07-01 12:35:21
    6Food 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

    Microsoft Worddoc

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    Source URL: www.fda.gov

    Language: English
    7Pharmacokinetics / Pharmaceutical industry / Clinical research / Bioequivalence / Generic drug / Bioavailability / Food and Drug Administration / Clinical trial / Pharmaceutical drug / Abbreviated New Drug Application

    Investigator Responsibilities in Protecting Participants in the Conduct of Bioequivalence Studies Cecilia C. Maramba, MD, MScID

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    Source URL: www.fercap-sidcer.org

    Language: English - Date: 2010-02-19 02:38:05
    8Food 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

    PUBLIC LAW 105–115—NOV. 21, 1997 FOOD AND DRUG ADMINISTRATION MODERIZATION ACT OF 1997 111 STAT. 2296

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    Source URL: www.gpo.gov

    Language: English - Date: 2012-03-21 10:56:20
    9Food 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

    Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry

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    Source URL: www.fda.gov

    Language: English
    10Drug discovery / Medicinal chemistry / Cyberinfrastructure / European Grid Infrastructure / Grid computing / Docking / In silico / Drug design / Drug resistance

    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

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    Source URL: grid.ucy.ac.cy

    Language: English - Date: 2007-03-06 04:27:04
    UPDATE