View source for Investigational Drugs & Devices

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== Investigational Drugs and Devices ==

'''Items Applicable to Investigational New Drugs (INDs)''' 
 
21 CFR 312 (CFR = Code of Federal Regulations) 
 
IND is required for all investigational drugs (except for a few radiopharmaceuticals)
  
Drug is not marketed in US  

Drug is marketed in US, but this is a new indication or route of administration  

Drug is a modification of existing drug (even the solution)  

IND “Sponsor” can be: Company; Institution (e.g.,hospital, NCI); Individual (usually physician)  

Application must be made to the appropriate FDA Division (CDER, CBER…)  

Specific data are needed for this application;  
#Pharmacology and toxicology information  
#Chemistry, manufacturing, and control  
#Dosimetry for radiopharmaceuticals  
#Important reporting requirements 
##Serious adverse events
##Annual report

FDA Guidance on IND process with multiple links to other documentation  http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm

Comprehensive FDA Guidance Page –  http://www.fda.gov/cder/guidance/guidance.htm 

A “how-to” guide from the Biological Development Program at NCI-Frederick with multiple links –  http://wwwbdp.ncifcrf.gov/pdf/GuidetoRegSubs.pdf

'''Investigational Device Exemptions (IDEs)'''
  
21 CFR 812 applies  

IDE is required for investigational devices that pose a significant risk  

Device is not marketed in US  

Device is marketed in US, but this is a new indication or modification  

“Significant risk” as determined by local IRB or by FDA  

IND “Sponsor” is responsible which can be: Company, Institution (e.g., hospital, NCI), Individual   

Application must be made to the appropriate FDA Division (CDRH, etc)  

#Important reporting requirements 
##Serious adverse events
##Annual and semi-annual report

Information resources: FDA Center for Devices and Radiological Health 
http://www.fda.gov/cdrh/index.html 
 
Device Advice:  http://www.fda.gov/cdrh/devadvice/