- [Benjamin] Hello, there.
Welcome to a poster presentation on teleconference,
which is an effective mode of communication
available to first cycle complete response DMF letters.
The purpose of this presentation is to show you
the process and steps for teleconference,
the review timelines here at the agency,
with regards to teleconference,
agency and industry responsibilities
and explain the grant-deny process and what it means.
My name is Commander Benjamin Danso.
So I'm the lead project manager
from the Office of Program and Regulatory Operations.
And I'm solely dedicated
in working closely with our Division of Lifecycle API,
In today's poster presentation,
I am here with one of our finest reviewers
in the person of Jayani Perera, who's a chemist
with the Division of Lifecycle API.
So teleconference
is popularly known
as DMF Meeting Requests.
So I would like to request for your full attention
for the next couple of minutes
so I can download these important information to you.
So teleconference is one of two modes of communication
established under GDUFA one
between the agency and the Drug Master File holder.
It is known to be a very effective part of communication
available to you industry,
in reference to deficiencies issued by the agency
upon completion of first cycle review of a Drug Master File.
Teleconference was first implemented under GDUFA one,
and then say it again is referred to by many
as the DMF Meeting Requests.
So the process and steps for industry.
DMF holders can and are encouraged
to submit a written request for a 30 minute teleconference.
The goal of this request is to discuss content
of the first psycho deficiencies
issued as part of the complete response letter.
DMF holders must not only request this in writing
but the request must be within 20 business days
from the time of receipt
of the complete response letter.
This request must identify specific issues
that needs to be addressed.
The written request should be submitted
through the electronic submission gateway
and should be followed with email notification
to the DMF, OGD mailbox
with a carbon copy
to the regulatory project manager
listed on the CR letter.
This helps to ensure that your request is received
with no glitches,
if any.
So the process and how it goes here at the agency.
When a formal meeting request is received from the industry,
the submission is processed as part of the DMF records,
whilst a review project is created in our review platform.
This review project is managed by the RBPM
in OPRO.
And OPRO stands
for the Office of Program and Regulatory Operations.
The RBPM assigns the review task to the review team
located in the Division of Lifecycle API.
From the time of receipt of a written request,
DLAPI
has 20 days to make a decision
on the submission.
Now, for those who do not know what DLAPI is,
DLAPI is the acronym that we use
for Division of Lifecycle API.
So to continue, your meeting request submission is qualified
as one of the following,
teleconference granted,
teleconference granted with written response
or meeting requests denied.
So now, let's look at a grant-deny decision.
When a written T-Con request is granted
it means that the agency is open.
Yes, we are open to have
that 30 minutes meeting
with the industry,
okay?
For a grant with a written response T-Con requests,
the agency issues a formal written documentation
to the industry.
And this documentation contains detailed explanation
to the issues
you brought to our attention.
At this point, the industry
have one of two choices to make.
That is industry can opt out of the 30 minute T-Con
should they find the agency's written response satisfactory,
or if not, then the RBPM
would work with a firm
to schedule a meeting.
So if you don't want to opt out
after receiving the written response,
you can opt in by reaching out to the RBPM
and have them work with you to schedule a meeting.
A meeting requests could be denied for other reasons,
most especially if the questions being asked
are not in relation to the CR letter you received
or your request is outside the 20 day window.
In this instance, an email exchange route
will be offered.
So on this slide here is a very simplified pictorial diagram
of the teleconference timelines.
So you see here that
we send you the complete response letter
and that is counted as day zero.
And you have from the date you receive it up until 20 days,
you the DMF holder, to sending the formal written request.
Once we receive that between days 20 and 40,
we make two decisions,
a meeting project is created by the RBPM
and a decision will have to be made by DLAPI.
Now, between days 40
and 50
is when we either grant or deny the request.
And then after day 50, a meeting is conducted
based on whether you are opting in or you are opt out.
Now, let's talk about
the email exchange route.
When a teleconference written requests
cannot be processed for any reason,
it is worth to know that the email exchange route
is just as effective.
DMF holders
will be notified in email,
should a T-Con request be denied
and change to email exchange.
It is worth noting that email exchanges
are not specific to a letter type,
neither are they subject to a review cycle.
So this mode of communication has gradually
become very popular with the industry.
It seems very popular with the industry,
so we encourage you to take full advantage of it.
Let's look further when it comes to email exchange
in lieu of teleconference.
When should industry decide which path to take?
Whether they should come the teleconference route
or do email exchange?
Please pay close attention.
Teleconference is limited
to first cycle DMF complete response letters only
and must be requested in writing,
20 business days upon receipt of your CR letter.
Very important.
The request must identify specific issues in the CR letter
that needs to be addressed in the teleconference.
A Division of Lifecycle API does have 30 days
to either grant or deny your request.
Now, email exchange.
When it comes to email exchange,
industry does have some flexibility on what qualifies.
I know that sounds great,
you do have flexibility on what qualifies.
Email exchange is not limited
to any particular type of letter.
So it is not limited to any particular type of letter
be it CR or DMR deficiency,
neither is it limited to a review cycle.
So this means industry may submit such requests
at any point.
So online T-Con,
email exchange does allow industry
to send in a followup request,
should you have any additional questions
in regards to our response, that is great.
On this slide, we would like to share with you
data comparing extent of T-Cons and email exchange.
So a side-by-side comparison of data collected
from fiscal year 2017
through fiscal year 2020.
Shows that the division of Lifecycle API
does have a review completion rate of over 97%
for T-con written requests and email exchange, big deal.
This is great accomplishment.
This comparison stands to show
the effectiveness of either communication pathways.
So either communication pathways,
we have proven by this data, to show to you
that both are very effective communication pathways.
However, it is very clear from the data
that industry does lean more towards email exchange
than teleconference.
So we would like to encourage you to start, if not already,
considering and understand that teleconference
is available to you and is just as effective
as email exchange.
It's exciting for me to present to you
that slides number 11
and 12
that stand to show how the agency has religious really stuck
with a GDUFA for two commitment.
So this data that you've seeing
shows you the number breakdown per fiscal year
from 2017 to 2020
of the total number of meeting requested,
the total number of meetings granted,
the median response time in days to grant meeting
or grants with written response.
And this particular slide is in relation
to the commitment that we made
for teleconferencing.
On this slide here,
it talks about our commitment on email exchange.
So this span from fiscal year 2018
through to fiscal year 2020.
It shows the total initial email exchange completed,
the median days to response
to initial email exchange,
total followup email exchange completed,
and the median days to respond
follow-up email let's change.
Now, we use these two slides
to let you know that both pathways are just as effective,
and again, you were encouraged to take advantage of them.
Now, here are some helpful tips to industry.
For questions regarding first cycle
complete response letters,
we encourage you
to utilize T-Con process
since these are direct meetings.
Follow the instructions on the CRL letter
to submit the T-con requests in a timely manner.
Industry has found email exchange as an effective option
and it's available in situations
where a T-Con is not appropriate.
And for costings, please reach out to us
at the listed email address.
Thank you,
and you may send your questions regarding this presentation
to the email address provided here
for DMFWorkshop2020@fda.hhhs.gov.
And you may also
refer to the following presentation on March, 3rd
for additional information
and that is effective communication strategies
for Drug Master Files or DMS
by David Skanchy and myself, Benjamin Danso
Once again, thank you.