Expanded Access Part 2: How to Submit a Single Patient IND

In this video, we will
discuss how to submit emergency and
non-emergency expanded access applications. For both drugs and
biologics, these applications are called
either a single patient IND or an emergency IND. In an emergency, you may
make a request to treat a patient with an
investigational drug before you submit
a written request. An emergency request may
be made by telephone, fax, or other means of
electronic communication. FDA may authorize an
emergency IND application over the telephone. You must report the
emergency treatment to an Institutional Review
Board within 5 working days and submit the
written request to FDA within 15 working
days of the initial authorization. An emergency IND timeline
is available on the FDA website to guide you
through the process. In a non-emergency
situation, you must submit a written request
to FDA before shipment of, or treatment
with, the drug. Treatment may proceed 30
days after FDA receives your application or upon
notification from FDA that expanded access use
may begin, whichever comes first. FDA has 30 calendar days
to review the request, but in most cases we
complete the review within a few days. If the Expanded Access
request is allowed to proceed, w we will notify
you either by phone or email and follow-up
with a formal letter. The letter acknowledging
receipt of your IND will include your IND number,
which may be requested by the company in order
to ship the drug. While office staff
and other healthcare professionals can help
with the administrative elements of preparing the
request to be submitted to the FDA, you, the
physician, must ultimately sign and be
responsible for the request. Follow these four
steps to apply. Step 1. Request a Letter of
Authorization The first step in any expanded
access request is to ask the pharmaceutical
company if they are willing to provide the
investigational drug. If the company agrees,
ask them to provide to you a Letter of
Authorization that grants you the right to
reference the information contained in the
company’s existing IND. If it is not possible
to obtain a Letter of Authorization, c contact
the applicable FDA Center and Review Division to
determine what other sources of information
may satisfy submission requirements
for your IND. A Letter of Authorization
template is available on the FDA website. Step 2. Submit Form FDA 3926 Form
FDA 3926 was specifically designed for single
patient expanded access requests submitted by
physicians and is the easiest way to apply. If you are familiar with
Form FDA 1571, you may still use that form. However, we encourage use
of the much simpler Form FDA 3926. For step-by-step
instructions on completing Form FDA 3926,
watch Part 3 of this video series. Step 3. Obtain approval from the
Institutional Review Board For a non-emergency
IND, you must obtain approval from an
Institutional Review Board prior to treating
a patient under expanded access. This is an important step
to protect the rights and safety of patients. However, we recognize
that assembling the full board may cause delays
if the board does not routinely meet. On Form FDA 3926, you can
indicate that you will obtain concurrence from
the IRB chairperson or from a designated IRB
member in lieu of full IRB review. Alternatively, when using
Form FDA 1571, a separate waiver request is
needed along with the application if you wish
to obtain concurrence from the IRB chair or
designee instead of full IRB review. IRB Requirements for
emergency treatment are discussed earlier
in this video. Step 4. Obtain informed consent
Obtain informed consent from the patient or
their legally authorized representative. Upon receipt of the
expanded access request, FDA will either allow the
treatment to proceed or place the application
on clinical hold. Clinical holds are
rarely necessary. If needed, we may contact
you for more information to process your request. For assistance, contact
FDA’s Division of Drug Information. If you’re already working
with the Review Division, give them a call.

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