Treatment IND

Results: 67



#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
    2Food 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

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    Source URL: www.fda.gov

    Language: English
    3Health / Medical research / Clinical pharmacology / Pharmaceutical industry / Food and Drug Administration / Design of experiments / Clinical research / Expanded access / Clinical trial / Institutional review board / Treatment IND / Investigational device exemption

    Special circumstances  regarding expanded  access at Stanford  In most circumstances, medical    research using  investigational  drugs, biologics and devices   

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    Source URL: humansubjects.stanford.edu

    Language: English - Date: 2016-04-12 01:21:50
    4Clinical pharmacology / Food and Drug Administration / Medical research / Clinical research / Pharmaceutical industry / Expanded access / Investigational New Drug / Adverse event / Clinical trial / Adverse effect / Treatment IND / Managed access program

    Expanded Access to Investigational Drugs and Biologics _______________________________When All Else Fails__________________________

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    Source URL: www.reaganudall.org

    Language: English - Date: 2016-05-24 12:16:34
    5Pharmaceutical sciences / Food and Drug Administration / Clinical research / Pharmaceutical industry / Drug safety / Expanded access / Investigational New Drug / Clinical trial / Health Insurance Portability and Accountability Act / Pharmacology / Health / Research

    Emory IRB Guidance for Investigators Guidance for the IRB Submission of an Expanded Access IND (Treatment or Emergency use) of an Unapproved Drug The guidance below is for use of an unapproved drug to treat a patient or

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    Source URL: www.irb.emory.edu

    Language: English - Date: 2015-02-04 16:48:22
    6Pharmaceutical sciences / Medicine / Expanded access / Treatment IND / Investigational New Drug / Clinical trial / Clinical research / Pharmaceutical industry / Methadone / Health / Pharmacology / Food and Drug Administration

    h e a lt h p o l ic y b r i e f 1 w w w. h e a lt h a f fa i r s .o r g

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    Source URL: healthaffairs.org

    Language: English - Date: 2015-03-04 09:44:55
    7Pharmaceutical sciences / Medicine / Expanded access / Treatment IND / Investigational New Drug / Clinical trial / Clinical research / Pharmaceutical industry / Methadone / Health / Pharmacology / Food and Drug Administration

    h e a lt h p o l ic y b r i e f 1 w w w. h e a lt h a f fa i r s .o r g

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    Source URL: healthaffairs.org

    Language: English - Date: 2015-04-09 08:15:32
    8Medicine / Pharmacology / Clinical research / Pharmaceutical industry / Drug safety / Investigational New Drug / New Drug Application / Clinical trial / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration / Pharmaceutical sciences / Health

    Guidance for Industry IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer U.S. Department of Health and Human Services

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    Source URL: rsdfoundation.org

    Language: English - Date: 2009-07-14 14:09:22
    9Food and Drug Administration / Research / Clinical research / Drug safety / Pharmaceutical industry / Investigational New Drug / Expanded access / Treatment IND / Clinical trial / Pharmacology / Pharmaceutical sciences / Health

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    Source URL: www.fda.gov.

    Language: English
    10Research / Health / Food and Drug Administration / Clinical research / Drug safety / Investigational New Drug / Expanded access / Treatment IND / Drug development / Pharmaceutical sciences / Pharmaceutical industry / Pharmacology

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    Source URL: www.fda.gov.

    Language: English
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