Investigational Drugs & Devices

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curator: Paula Jacobs, PhD

Items Applicable to Investigational New Drugs (INDs)

21 CFR 312 (CFR = Code of Federal Regulations)

An Investigational New Drug Exemption (IND) is an exemption from the requirement that all drugs be approved by the Food and Drug Administration (FDA)before distribution. An IND is required for all investigational drugs (except for a few radiopharmaceuticals)for which:

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 or concentration)

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 information are needed for this application;

1. Pharmacology and toxicology information
2. Chemistry, manufacturing, and control
3. Clinical trial information
   1. Trial Protocol
   2. Investigator qualifications
4. Dosimetry for radiopharmaceuticals
5. Previous human experience
6. Important reporting requirements
   1. Serious adverse events
   2. Annual report

Useful outlinks:

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

FDA guidances on developing imaging drugs:

Part 1: Conducting Safety Assessments http://www.fda.gov/cder/guidance/5742prt1.pdf

Part 2: Clinical Indications http://www.fda.gov/cder/guidance/5742prt2.pdf

Part 3: Design, Analysis, and Interpretation of Clinical Studies http://www.fda.gov/cder/guidance/5742prt3.pdf

Investigational Device Exemptions (IDEs)

21 CFR 812 applies

IDE is required for investigational devices that pose a significant risk when:

Device is not marketed in US

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

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

IDE “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/