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.