Understanding FDA regulatory requirements for investigational new drug applications for sponsor-investigators

Journal of Investigative Medicine

Volumn 57, Issue 6, 2009, Pages 688-694

  Holbein, M E Blair ^a  

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

Author keywords

Federal regulations; Food and drug administration; Investigational drug studies; Investigational new drug; Sponsor investigator

Indexed keywords

DATA BASE; DOCUMENTATION; DRUG APPROVAL; DRUG CONTROL; DRUG LABELING; DRUG LEGISLATION; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; REGISTRATION; REVIEW;

HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; RESEARCH SUPPORT AS TOPIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 70349247863     PISSN: 17088267     EISSN: None     Source Type: Journal    
DOI: 10.2310/JIM.0b013e3181afdb26     Document Type: Review

References (18)

1. Federal Food, Drug, and Cosmetic Act.
2. CFR Title 21 Part 312. Investigational New Drug Application.
3. CDER Original INDs Received, Calendar Years 1986Y2006. January 29, 2007. Available at: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/UCM165257.pdf. Accessed June 16, 2009.
4. Center for Biologics Evaluation and Research Organization. May 28, 2009. Available at: http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/ ucm135943.htm. Accessed June 16, 2009.
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6. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research. Available at: http://www.fda.gov/ downloads/AboutFDA/CentersOffices/OrganizationCharts/UCM144011.pdf. Accessed June 16, 2009.
7. CFR Title 21 Database Search. April 1, 2008. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart= 312. Accessed May 14, 2009.
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9. Code of Federal Regulations Title 21 Part 310. "New Drugs".
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12. Division of Antiviral ProductsVODE IV Pre-IND Consultation Program. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/ InvestigationalNewDrugINDApplication/Overview/ucm077776.htm. Accessed June 16, 2009.
13. Investigational New Drug (IND) Application. June 2, 2009. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/ InvestigationalNewDrugINDApplication/default.htm. Accessed June 16, 2009.
14. Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs). April 30, 2009. Available at: http://www.fda.gov/Drugs/ DevelopmentApprovalProcess/SmallBusinessAssistance/ucm071098.htm. Accessed June 16, 2009.
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16. US Public Law 110-85 (Food and Drug Administration Amendments Act of 2007), Title VIII, Section 801.
17. Protocol Registration System Information. Available at: https://register.clinicaltrials.gov/. Accessed May 14, 2009.
18. Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff. Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance With Section 402(j) of the Public Health Service Act, Added By Title VIII of the Food and Drug Administration Amendments Act of 2007. June 8, 2009. Available at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm. Accessed June 16, 2009.