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Guidance for Applying for an Investigational Drug Permit 


Resources for Physicians and Patients:

FDA Investigational New Drug (IND) Application main page:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm#Introduction


Access to Investigational Drugs page:

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/default.htm


Physician Request for an Individual Patient IND under Expanded Access for Non-Emergency or Emergency Use:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm107434.htm


IND Forms and Instructions:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm071073.htm


FDA Guidance - Expanded Access to Investigational Drugs for Treatment Use - Qs & As:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM351261.pdf


FDA Guidance - Charging for Investigational Drugs Under an IND - Qs & As:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM351264.pdf




Search for a Trial:

U.S. National Institutes of Heatlh Clinical Trials database:

https://clinicaltrials.gov/