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Investigational New Drug
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51	21 CFRb)(1) To be exempt under this category, all of these sub-requirements must apply: The clinical investigation involves a drug product lawfully marketed in the U.S. Yes The investigation is not intended to be Add to Reading List Source URL: research.unc.edu Language: English - Date: 2013-04-10 14:57:04 Pharmacology Pharmaceuticals policy Drug safety Food and Drug Administration Food law Prescription medication Title 21 of the Code of Federal Regulations Investigational New Drug Investigational Device Exemption Medicine Health Pharmaceutical sciences
52	CONFIDENTIAL Investigator’s Brochure CONFIDENTIAL Investigational Product Insert company logo Investigator’s Brochure CONFIDENTIAL Add to Reading List Source URL: www.health.qld.gov.au Language: English - Date: 2013-10-01 01:47:33 Pharmaceutical sciences Clinical research Design of experiments Drug rehabilitation Pharmaceutical industry Investigational New Drug Bioavailability Clinical trial Pharmacology Chemistry Food and Drug Administration Medicine
53	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Clinical research Clinical Data Management Drug safety Medical informatics Electronic Common Technical Document Investigational New Drug Common Technical Document New Drug Application Office of Regulatory Affairs Medicine Research Food and Drug Administration
54	PDF Document Add to Reading List Source URL: research.unc.edu Language: English - Date: 2015-03-02 09:36:58 Investigational New Drug Medical research Clinical research Research Health Pharmacology Institutional review board Drug safety Food and Drug Administration Medicine
55	PDF Document Add to Reading List Source URL: research.unc.edu Language: English - Date: 2015-03-02 09:36:58 Investigational New Drug Medical research Clinical research Research Health Pharmacology Institutional review board Drug safety Food and Drug Administration Medicine
56	PDF Document Add to Reading List Source URL: research.unc.edu Language: English - Date: 2014-01-13 15:29:18 Science Food and Drug Administration Medical statistics Pharmaceutical industry Pharmacology Clinical trial Investigational New Drug Health Insurance Portability and Accountability Act Protected health information Health Clinical research Research
57	PDF Document Add to Reading List Source URL: www.fda.gov. Language: English Food and Drug Administration Research Clinical research Drug safety Pharmaceutical industry Investigational New Drug Expanded access Treatment IND Clinical trial Pharmacology Pharmaceutical sciences Health
58	DOC Document Add to Reading List Source URL: research.unc.edu Language: English - Date: 2013-08-07 08:12:29 Health Clinical research Drug safety Food and Drug Administration Design of experiments Investigational New Drug Institutional review board Medical record Expanded access Pharmacology Medicine Research
59	PDF Document Add to Reading List Source URL: www.fda.gov. Language: English Research Health Food and Drug Administration Clinical research Drug safety Investigational New Drug Expanded access Treatment IND Drug development Pharmaceutical sciences Pharmaceutical industry Pharmacology
60	ANNEX – 1 AFContinuing Review Application Form PROTOCOL No.: PROTOCOL TITLE: Principal Investigator: Site……………… Add to Reading List Source URL: www.health.gov.bt Language: English - Date: 2014-11-24 01:41:33 Food and Drug Administration Accrual Investigational New Drug