Investigational Drugs & Devices

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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;

1. Pharmacology and toxicology information
2. Chemistry, manufacturing, and control
3. Dosimetry for radiopharmaceuticals
4. Important reporting requirements
   1. Serious adverse events
   2. 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

1. Serious adverse events
2. 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/