Manual of Standard Operating Procedures and Policies

Regulatory - Investigational Biologics

Emergency INDs

SOPP 8205

Version #1

October 22, 2007
  1. Purpose

The purpose of this document is to describe the policies and procedures for Center of Biologics Evaluation and Research (CBER) staff to use for granting or denying emergency use of an investigational biologic and drug.

  1. Definitions

Emergency IND Use – An investigator or practitioner uses an unapproved biologic or drug after telephoning the Agency and receiving authorization to have the product shipped and administered generally to one patient in advance of submission of an Investigational New Drug Application (IND) because of an urgent medical need.

  1. Background

21 CFR 312.36 permits the Agency to authorize emergency use of a biologic or drug. In the past, the procedure for granting such emergency use required the CBER reviewer to obtain an IND number from the Document Control Center (DCC). At times, particularly after normal working hours, this was cumbersome. Also, there was no record kept of emergency use requests that were denied. With changes to the CBER database Biologics Investigational and Related Applications Management System (BIRAMS), the process has been streamlined and tracking of all requests whether granted or denied is now feasible. This SOPP describes the new process.

  1. Policy

Emergency INDs will be granted or denied by the product review offices (the Office of Blood Research and Review [OBRR], the Office of Cellular, Tissue, and Gene Therapies [OCTGT], and the Office of Vaccines Research and Review [OVRR]) in accordance with 21 CFR 312.36 and the procedures described below. All such requests will be entered into Biologics Investigational and Related Applications Management System (BIRAMS).

Each product review office will have specific reviewers authorized to grant or deny emergency IND requests.

If the sponsor requesting emergency use of product already has an active IND for the same product and use, the emergency use should be granted under the sponsor’s existing IND, i.e., new and separate INDs should not be created for each separate patient.

Emergency use of a device regulated under an Investigational Device Exemption (IDE) does not require pre-approval by FDA, and therefore should not be granted on the basis of a telephone request.

  1. Responsibilities and Procedures

    1. Emergency IND telephone requests may come into CBER to the Office of Communication, Training, and Manufacturers Assistance (OCTMA), or directly to the product review office.
    2. After normal working hours, the initial call may come into the FDA Office of Emergency Operations, which will forward the call to the Center designated contact.
    3. If received by OCTMA, the office responsible for the biologic or drug should be determined and the call should be forwarded to that office immediately.
    4. Upon receiving the call, the product review office should identify and forward the call to the appropriate reviewer authorized to grant or deny emergency IND use requests.
    5. The list of authorized reviewers should be available to anyone in the product offices who may receive the requests. Any staff additions or deletions should be sent to the Regulatory Information Management Staff (RIMS) using the CBER RIMS email address to assure that the necessary reviewers have access to the emergency use screen in BIRAMS.
    6. The reviewer should enter the following information into the Emergency Use screen in BIRAMS:
      • Review Office (displays based on CBER person’s office),
      • Telecon Date and Time (defaults to current date and time)
      • Contact Name
      • Contact Telephone Number
      • Sponsor Name
      • Sponsor Address
      • Product
      • Proposed Emergency IND Use
      • Conversation Summary
      • FDA Telecon Participants (first name in list defaults to person entering telecon)
      • Sponsor Other Telecon Participants (if any)
      • Whether the emergency IND is authorized or denied. This will automatically enter the appropriate telecon category into the system.
    1. All of the above information is required to save the record in the system. If the record is saved, the system will generate an IND number. If the emergency use is authorized, the number should be given to the sponsor. If the request is denied, the number must not be given to the sponsor.
    2. BIRAMS automatically creates a telecon record when the emergency use information is saved. The telecon summary should be rendered as a PDF document and loaded into the EDR. Supporting documents received before the decision is made to grant or deny the request should be filed in the appropriate record keeping system. Electronic documents, such as emails, from the requestor should be loaded into the EDR Telecon folder along with originating telecon. Facsimiles or other paper documents should be sent to the DCC for inclusion in the IND correspondence volume.
    3. The responsible Regulatory Project Manager (RPM) should send an emergency IND acknowledgement letter to the sponsor along with the forms and instructions to be completed and returned (Emergency IND Acknowledgment Letter).
    4. If the forms are not returned by the sponsor within 30 days, a follow up letter should be sent by the RPM (Emergency IND Follow Up Letter).
    5. If the forms are not received within 30 days of the follow up letter, the RPM should send a cancellation letter to the sponsor (Emergency IND Cancellation Letter).
    6. The IND should be cancelled if the sponsor informs CBER that the drug was not and will not be administered, and the forms have not yet been submitted, or if no response is received from the sponsor to the follow up letter.
    7. Letter templates can be found on CBER’s Intranet.
  2. References

    Title 21 Code of Federal Regulations Part 312.36
    Template Letters:
    Emergency IND Acknowledgment Letter
    Emergency IND Follow up Letter
    Emergency IND Cancellation Letter

  3. Effective Date

October 15, 2007

  1. History
    Written/Revised Approved Approval Date Version
    Number     		Comment
    Roger Eastep
    RMCC
    Robert Yetter
    		 October 11, 2007
    1
    First issuance of this SOPP

 
Updated: October 15, 2007