Expanded Access to Investigational Drugs for Single Use

IRB EDUCATION FOR FEBRUARY 2013

Expanded Access to Investigational Drugs for Single Use

Tejal Patel, JD, Contracts/Compliance Administrator for the division of research at Palmetto Health, will be presenting the IRB education at the board meetings during the months of February and April, 2013. She will be addressing expanded access to investigational drugs as follows:

1) Non-Emergency Treatment IND for Single Use

2) Emergency IND for Single Use

Ms. Patel will be using slide presentations for this education, which will included in the eIRB education folder for your reference in the future.

TEACHING OBJECTIVE:

Define and delineate major differences in the application processes for obtaining a non-emergency treatment IND versus an emergency IND for single use with one patient.

An array of resource documents and weblinks are included below for your reference as desired.

PDFs of FDA Documents

Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)

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

FDA WEBSITE LINKS

Physician Request for an Individual Patient IND under Expanded Access for Non-Emergency or Emergency Use (updated 02-13-2012)

Information for Sponsor-Investigators Submitting Investigational New Drug Applications (updated 07-27-2011)

FDA Form 1571 – Investigational New Drug Application (updated 12-2012)

FDA Form 1572 – Statement of Investigator (updated 02-2012)

Federal Register – Expanded Access to Investigational Drugs for Treatment Use (08-13-2009)

(Warning: This is 46 pages long so think before you print!)

FEDERAL REGULTIONS

21 CFR 312 – Investigational New Drug Application

Subpart C – Administrative Actions

Section 40: General requirements for use of an investigational new drug in a clinical investigation (referenced regulation for Form 1571)

Subpart D – Responsibilities of Sponsors and Investigators

Section 53: Selecting investigators and monitors (referenced regulation for Form 1572)

Subpart I – Expanded Access to Drugs for Treatment Use

Section 300: General

Section 305: Requirements for all expanded uses

Section 310: Individual patients, including for emergency use

Section 320: Treatment IND or treatment protocol

21 CFR 56 – Institutional Review Boards

Subpart A – General Provisions

Section 102: Definitions

Section 104: Exemptions from IRB requirements