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Investigational New Drug
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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	Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Add to Reading List Source URL: www.fda.gov
3	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
4	Microsoft Word - 7494fnl.doc Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical industry Food and Drug Administration Pharmacology Pharmaceuticals policy Food law Food safety Good manufacturing practice Compounding Title 21 of the Code of Federal Regulations Federal Food Drug and Cosmetic Act Investigational New Drug
5	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
6	Albert Einstein College of Medicine Center for Experimental Therapeutics A Bold New Initiative Add to Reading List Source URL: einstein.yu.edu Language: English - Date: 2015-08-28 12:37:32 Health Medical research Pharmaceutical sciences Pharmaceutical industry Clinical research Drug discovery Food and Drug Administration Clinical trial Drug development Investigational New Drug Pharmaceutical drug Albert Einstein College of Medicine
7	Instructions Questions? Contact the IRB Education Specialist atSee guidance GUI-6 and HRPP Policy Manual Chapter 5.9. Report to IRB The protocol director must submit the following to the IRB within five ( Add to Reading List Source URL: humansubjects.stanford.edu Language: English - Date: 2016-04-12 01:21:50 Medical research Medical ethics Research Health Autonomy Clinical research ethics Food and Drug Administration Informed consent Expanded access Investigational New Drug Consent Clinical trial
8	Microsoft Word - SOP - Emergency Use of a Test Article.doc Add to Reading List Source URL: research.missouri.edu Language: English - Date: 2015-07-01 12:42:30 Medical research Medical ethics Research Applied ethics Clinical research ethics Drug safety Human subject research Clinical research Institutional review board Food and Drug Administration Investigational New Drug Informed consent
9	 HOME STUDY Daily Challenges to the Future of Clinical Trial Conduct Drug Products for InvestigatorInitiated Research PEER REVIEWED \| Philip K. Burns Add to Reading List Source URL: www.acrpnet.org Language: English - Date: 2016-03-31 09:50:44 Pharmaceutical industry Clinical research Drug development Validation Food and Drug Administration Good manufacturing practice Clinical trial Verification and validation Investigational New Drug Pharmaceutical drug Drug discovery Quality management system
10	Expanded Access to Investigational Drugs and Biologics _______________________________When All Else Fails__________________________ Add to Reading List Source URL: www.reaganudall.org Language: English - Date: 2016-05-24 12:16:34 Clinical 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