FDA Webinar

Moderator: Irene Aihie

2-12-19/3:00 pm ET

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FDA Webinar: Coordinated Development of Antimicrobial Drugs

and Antimicrobial Susceptibility Test Devices

Moderator: Irene Aihie

February 12, 2019

3:00 pm ET

Coordinator: Good afternoon and thank you for standing by. I’d like to inform all 

participants that your lines have been placed in a listen-only mode until the 

question-and-answer session of today’s call. Today’s call is also being 

recorded. If anyone has any objections, you may disconnect at this time. I 

would now like to turn the call over to Ms. Irene Aihie. Thank you. You may 

begin. 

Irene Aihie: Hello, and welcome to today’s FDA webinar. I am Irene Aihie of CDRH’s 

Office of Communication and Education. On January 17 the FDA issued the 

final guidance document, Coordinated Development of Antimicrobial Drugs 

and Antimicrobial Susceptibility Test Devices. The goal of the guidance is to 

minimize time between the approval of new antimicrobial drugs and the 

clearance of antimicrobial susceptibility tests for those drugs, and to provide

recommendations to the medical device and drug industry, on how to work 

together to facilitate timely antimicrobial susceptibility test device clearance 

by the FDA. 

Today, Dr. (Ribhi Shawar), Branch Chief in the Division of Microbiology 

Devices, here in CDRH, will present an overview of the guidance document. 
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Following the presentation, we will open the lines for your questions, related 

to the information provided during the presentation. Additionally, there are 

other center subject matter experts here, to assist with the Q&A portion of 

today’s webinar. Now, I give you (Ribhi). 

Dr. (Ribhi Shawar): All right. Thank you, Irene, and thanks to Dr. John Farley being here as 

well. Good afternoon everyone and welcome to the AST coordinated

development webinar. We’ll go over the outline of the presentation. First, 

we’ll go over some background and types of devices and important 

regulations. Then go over some FDA review of traditional drug and device 

submission. Highlight the concerns about the antimicrobial drug approvals 

and availability of AST devices. 

And talk about coordinating development activities that have been growing on 

FDA mind and finally end with some highlights. our objectives. The aim of 

the webinar is to familiarize stakeholders with the (history) of coordinated 

development of antimicrobial drugs and antimicrobial susceptibility test 

devices. And you will hear me a lot saying AST devices that have from now 

on, but for the couple of times perhaps we’ll say the full words, so that people 

understand. 

And so, we go over that again, the peer review process for the availability of 

AST devices. And also, to provide an update on FDA guidance for 

coordinated development and the various supportive activities. On slide 

number 5, perhaps we’ll start with some definitions. Like I said, antimicrobial 

susceptibility test devices or AST devices. Suffice it to say that these devices 

and drugs are regulated by FDA as many of the people on the call of course, 

know. But specific to this topic today, what is an antimicrobial susceptibility 

test device? 
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Is an antimicrobial susceptibility test that incorporates concentrations of 

antimicrobial engines into the system? So, the purpose of determining and 

retest susceptibility of isolates that are selected from clinical specimens 

typically. Test results steps, are used to determine the antimicrobial agent of 

choice or help the physician in their choice diseases. 

That’s the regulatory devices and the different regulations and uses multiple 

products depending on the device. And on slide 6, again, I think many of the 

people I expect who are on the call and have interest in these devices, do not 

need a lot of definitions here. But for the purpose of that and so everybody is 

on the same page, there are various types of AST test devices, from (film) 

devices such as the fusion based devices, they may have or they’re valuation 

based devices, which come in also various formats. 

And concentration, for example, those devices, there are . Those devices that 

are instrument for example, such as both and they have algorithm in other the 

type of result that the has. There are variations in test methods and those can 

include the method and conflicts of their implementation. The point on this 

slide is really not to again, lecture on this topic specifically. 

But to highlight that because of these differences in devices the point of the 

slide is to provide a value that - or highlight that because of these differences, 

there are - I think they could be considered or should be considered, 

particularly on this topic of development, because some development will 

require a little bit more elaborate studies up front than other. On this - on 

slide 7 now, these are the relevant susceptibility test devices; their reviews, 

their regulations, and guidelines. These devices are two devices. They 

require a five market notification and therefore they are nonexempt. 
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But in the detailed timeline they are subject to the same type of timelines that 

are other devices as well. They’re subject to a 90 day review cycle. They are 

under the regulations in regulation, and there are numbers here of the various 

regulations the slide. But suffice to say, that depending on the device side, 

your tactical regulation is outlined there. 

(CDER), our sister agency center, for research, and (TVRS), have various 

guidelines that outline the type of studies, the data requirements, evaluation 

criteria. And there are in addition, many FDA recognized guidance and 

standards, for example, such as standards from standards that also are needed 

to govern the type of study and evaluations that are invested for these studies. 

Now on this slide this is a slide that actually is just showing here the diversity 

of for AST test devices and devices that have the resistance marker. I’m not 

going to read this slide again. Suffice it to say that you see on the slide the 

various test methods. For example, subculture media that detect resistance for 

test devices that are disks for regulation for a connected system. Another 

regulation for nucleic acid tests and direct for specimen, are also for manual 

susceptibility test devices. 

Lot of abbreviations on this slide and some of them are defined below. Again, 

I’m showing this slide in order to also highlight that because of the various 

regulations, there are indeed in these various CFR, the data and the 

performance that is required, is part of that kind of evaluation that we have to 

go through, because of the differences that are taken into consideration. 

Now the - this is a - on this slide 9, so this is a review of traditional drug and 

device submissions. Here are two sides of this. There’s the drug 

manufacturer and there’s a device manufacturer. So, we go on the left side 

first. The drug manufacturer, this is the usual, traditional process. By no 
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means is this is oversimplifying obviously the drug reviews as well as the 

device reviews. 

But it was the first . The drug manufacturers usually have investigation in a 

drug or (RND) application. These are reviews. Then the new drug 

application submission and is reviewing that on the device side. The 

traditional way the device manufacture then they do the studies, have met the 

direct for review, and then an AST susceptibility review test is clear. 

And the center on the slide, the final breakpoint and indicated all of this are 

the factors that play into the type of evaluation that needs to be conducted and 

that of the firm analysis such as the evidence on the break points, for 

evaluation of the . There are a couple of slides here that I’m going to go over. 

The as the devices - to highlight what are the studies, the usual studies that 

are associated with which thing. And this slide is about the drug and again, 

this is not meant to really - it was meant only to highlight the - in a high level, 

the type of surveys that are conducted in which (way). 

When is it meant to give a detailed look on how things are evaluated? So, for 

anything like those drugs, the timelines usually are the phase ones, are 

(IMDM) and then phase one for two and three, and then the NDA. And 

various activities are taking place at the various phases. For example, in the 

(IMDM) phase one, there’s basic microbiology profiling, research and 

development. There’s not an evaluation mechanism of action . 

Then later on the - for example, the potency studies are included as - in later 

phases and then microbiology trial, that his data is part of the NDA, which 

includes reference methods for consolidation. For example, in (CDER) 

review the quality (control rates) and breakpoints and decide on that. The 
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next is about the AST device time management. And the first one is for the 

form of AST devices that we think of as the disk diffusion. That’s us. 

And in that the - just for simplicity here two phases as an area of research and 

development, where the drug manufacturer perhaps is working with the disk 

manufacturer to produce either an investigational or RUO disk for that 

particular drug for the in terms to do. And then following that, the current 

traditional path is that the disk manufacturer data to CDRH if the data was 

already submitted to (CDER) for evaluation during the drug of the evaluation. 

In that scenario, the device comes in as it has been to (CDRH)). And I will 

explain some other scenarios for other types of submission to CDRH. So that 

is if the device is a disk. If the device is a concentration, again similar 

processes going on the device manufacturer is working to develop a particular 

test so that it’s a manual test, whether it’s a and algorithm driven assessment 

or instrumentation. 

And once that data is collected the (510K) is submitted and the CDRH 

evaluates the data including the MIC and the breakpoint for the indicators’ 

organism. Again, that’s the review of the 90 days and some additional 

information data is needed. So, this is now getting really to the meat of the 

topic of today. The - this is the kind of vision that we have been noticing 

when FDA began looking into this topic and hearing information from 

stakeholders, about the delay in availability of antimicrobial susceptibility test 

devices after a drug approval. 

So, let me explain this graphic a little bit more on the - you see the drug 

approval time point of the zero and then we have on the X - on the X axis the 

time in months. The main point of this slide is blue is bad, because blue is a 

long time for a device manufacturer to have come into FDA in order to 
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request for clearance. So, this is really nothing to do with FDA review at 

CDRH per se. So, when we observed this, we saw that given for some of the 

devices as I mentioned earlier, the AST disk is a simple device. Even some of 

those we’re requiring upwards of almost like eight months for some of these 

devices. 

And the longer ones are the devices that measure antimicrobial susceptibility 

tests by MIC for example. And some of these devices are automated devices. 

So, the length of time where there is no AST device, but the drug on the 

market has been a great and that really what has led the FDA and others, to 

come together and to do something about it. 

And so, we are now into this coordinated development where it requires 

various stakeholders in order for this program to be successful. The drug 

manufacturer needs to be involved, the device manufacturer needs to be 

engaged, and (CDER) and CDRH internally here as well as externally, with 

the respective manufacturer, be working together to make this program 

effective. 

And so, SDA on had a coordinated development workshop in September of 

2016 and coinciding with that date as well, issued the drug that we are today 

discussing the final version of it. There in the workshop as well as in later 

information that was exchanged through the , FDA invited to the workshop, 

and we went through an overview of AST devices landscape and had some 

different perspective from the perspective of the commercial, from the 

perspective of the lab, drug sponsors and diagnostic (devices) as well as other 

stakeholders such as the (ISM), CDC and others. 

And two panels were dedicated to help clarify some of the questions from the 

audience of the workshop. On slide 16 now after the guidance document, 
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after the draft guidance document was issued, there was a docket open for that 

and received comments. So, here I’m summarizing the - in general kind of 

comments that were received from stakeholders. Fifty-four comments were 

received, 46 were from industry, 11 from professional (societies), 7 from 

(data) associations. There were four common themes or types of the 

comments, if you will. 

Ten were about policy, nine were from comments, 19 were about procedure 

issues and 16 were technical. There were substantive changes to the content 

of the draft guidance and we’ll go through some of that here. But here is the 

scope of the guidance. The scope of the guidance, it is in terms to assist drug 

sponsors and device manufacturers that are planning to develop new and and 

AST devices. 

Specifically, the guidance intends to accomplish the following, describe the 

interactions that are needed in order to achieve coordinated development, 

extend the consideration for submitting separate application, for example, 

(CDER) for evaluation of the drug and CDRH for the evaluation of the device 

. 

The driver is to clarify the review of both the antimicrobial drug product and 

the antimicrobial AST device when independent and separate. So hence, the 

idea is coordinated and not necessarily (co-linked). So, the goal of the 

guidance is to be summarized by . It provides recommendations to the device 

and the drug indices and how to work together to facilitate the time to 

clearance of AST devices by FDA. 

Then hopefully achieve the goal of memorizing the time that you need 

approval of the new drug and the other commercial AST test that is used to 

determine the potential effectiveness of the drug. On slide 19 I’m showing 
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side by side, the draft of the final published guidance, the document. So, 

while we go over a couple of slides about what some of the highlights of the 

changes that put this from a draft to a final, services summary of those joined. 

First, on the threshold circle development, the final version of the guidance 

we hope, clarifies the process and timeline for coordinated development and 

in AST devices. And added a flowchart that depicts the recommended 

interaction between drug and device manufacturers, (CDER) and CDRH to 

facilitate coordinated development. And one other important point was added 

to the guidance the final guidance document, is the applicability of the 

guidance of molecular devices. 

As we all know, there’s more and more of these types of molecular devices 

that detect antimicrobial resistance for example. So, the to indicate that if 

there were an effort to coordinate development of a device that is a 

(molecular) type of device, that there are the principles that apply here to 

regular routine AST devices, are also applicable (molecular) markers of 

resistant type of devices. 

Now there are changes to considering that changes to the final guidance, 

based on comments to the . There were clarifications of the following as well. 

The need for improved coordination between drug and device development; 

process for coordinated development clarified; the types of antimicrobial -

AST devices to include medical devices as I just mentioned; recommended 

timing for submission of AST CDRH iteration submission of new drug 

application to (CDER). I’ll explain this a little bit more. 

And the process according without a pre-submission that could be also 

received without then need for for a pre-submission. And the content of a 

pre-submission, if that is what . This - we’ll spend some time on slide 22 
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because this in fact is one of the main additions that were made to coordinated 

development final guidance. So, the flowchart just provides a little bit more 

transparency about the kinds of steeps that are needed. So, from an AST 

device manufacturer, for example, could if that - if they were the ones 

initiating a process for coordinating development because the pre-submission 

process can also be initiated by drug sponsors as well. 

This is something important I wanted to also mention. But for the sake of this 

slide, it’s showing an AST device manufacturer submitting for example, a presubmission or a pre-submission supplement, depending on if there were more 

than one communication on the topic. In that, a sponsor, a device 

manufacturer will put their plans to coordinate development, they are 

described - description of their relationship with the drug sponsor for example. 

The anticipated need for an IDE in case of such a device for example, would 

be more applicable to a new device or another device that is providing results 

that may perhaps be useful for the patient to know the results. Again, for the 

sake of this call, we’ll not go beyond that to explain this further. If people 

have questions, perhaps we can answer that later on. 

And they provide the plans for the data collection and analysis and they share 

their (510K) plan. A pre-submission comes into CDRH for review. A (510K) 

release submitted, was the new drug application is under review. This is very 

important. And it has to be coordinated very well between the parties that are 

involved, because the timeline for the drug and NDA is longer - perhaps 

longer than the view for CDRH, which is 90 days. 

So, but with good coordination it could be a case where the data, all of the 

data that need to be coming in, so that we can come as close as possible to an 

AST device being cleared, when the drug gets cleared. The device 
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manufacturers can work in such a way to coordinate that the submission 

comes in to see the rest reviews as a (510K), so that the timing of the AST 

device cleared can be coincidental or close to the time of the drug approval. 

We all know that can go and requests can be made by (CDER) for example, 

or during the review session. But this is assumed that it’s a good streamlined 

process. Then the pre-submission is not necessary, but it is recommended 

during the development. In other words, if drug and device manufacturers are 

working together in a coordinated manner, and then the data comes in, in a 

timely manner, to CDRH, CDRH knows (CDER) actions to be involved in 

that process. However, we find that the - those two utilize the of receiving 

feedback, have resulted actually in very good outcome, and I’ll share some of 

this in a later slide. 

That the process seemed to work as we all intended, such that patients have 

the available devices, so that data for their healthcare management. And so, 

device can either coincide with or be shortly after drug approval. And like I 

said, I will sure the information in a couple of slides, about how this process is 

working. But a few points about the functions of coordinated development. 

And we look at this one as the work does it do and what does it not do. 

The coordinated development does not do or it’s not meant to change existing 

regulatory requirements or timelines for either the drug or the device approval 

or . I wanted to amok that point very, very clear. And I think people on the 

call do understand that. So that’s about coordination and not about changing 

any of the existing regulatory requirements. (CDER) will require what they 

will require, CDRH will require what is guided by the various guidance 

documents that I will share at the end of this slide, some of the reasons. 
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But what it does which is a logical extension of all that we’ve been talking 

about is that the idea is that a streamline the time between the approval and 

device here, AST device here, promote a meaningful discussion between drug 

developers and device manufacturers and the branches of FDA. And provide 

drug developers access to AST device technology, during clinical studies. 

This is an option. This is something that perhaps a drug manufacturer might 

be more interested in coordinating a little bit more of. I mentioned earlier that 

a pre-submission process for example, for CDRH, is usually typically coming 

in some device manufacturers. But in fact, we can enhance the drug 

manufacturers coming in asking for that type of coordination, wherever it is 

through (CDER) or through CDRH. So, we encourage more of that actually, 

because they are the ones that are insistent in having those drugs on certain 

panels for example. 

And the coordinated development provides device manufacturer aces to 

organisms again getting and if there is coordination. Those are usually often 

being hidden in finding certain organs in certain types. And because the drug 

manufacturer usually is conducting the trials, we have access to that that 

perhaps would be helpful in coordinating the studies occurring sooner than 

later. And finally, to patient care is what we are all looking to do. The 

interaction topics - what can interactions be looking like, or what are the 

general things that should be considered for when requesting coordinating 

development or when asking about coordinated development? 

In general, it’s an outline of the studies that would have been or maybe will 

be, performed. Information about provisional breakpoints and indicated 

organism because some of that information may be because you are - the drug 

is now in early stages of an NDA in some of that. And some version might be 
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more. And the drug and device manufacturers can work together on that and 

can ask questions about that. 

Expectations of the timeline for example, when we are expected to come in 

and are ongoing, how long. What important aspect that is getting a little bit 

technical here, but an assessment of benchmark or valuation variability can be 

an issue and it has been in the pasted, an issue. And that has thrown the 

development of devices, of commercially available devices because of some 

aspect like that where there may be a need for addressing variability or a 

certain adjective that is required for methodological changes in the past. 

So, those are important aspects to be addressed earlier than later, and 

therefore, could be issued as topics of interaction in a pre-submission, to talk 

about coordinated development. And to procurement of resistant or (unscale) 

for example, could be asked. And if - feedback could be when you from here 

or maybe you found it here or maybe it can have a case where all of these can 

become available and I mentioned something about that in the last couple of

slides, at the end of the presentation. 

We can share information regarding the drug and the device agreement that 

there are in place between the drug manufacturer and device or any other 

entity for that matter, and any specific questions to allow better FDA 

feedback. On slide 25, again, these are specific topics that would be - can be 

added to the interaction. For example, can be provided by the drug 

manufacturer? In other words, the drug manufacturer has conducted studies, 

have collected isolates and could those at a higher dose, could be made 

available so that they can facilitate the development of AST devices? 

Organisms from drug evaluation studies can be used as challenge or . 

Questions can be where can we get those; how can we get those; which part of 
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studies we can include those? Those are the types of questions that can 

interaction between the sponsored and FDA perhaps (end). One important 

factor is in planning this studies is the factors, for example it is advised that 

they should test a wider range of (dimensions). 

And this allows flexibility for the changes. I cannot emphasize this point 

enough because oftentimes we find ourselves delayed in those progressions 

simply because we need to go back in order to be more steady, had we done 

the studies using the device that would have covered those breakpoint 

changes. This point point about this is something I mentioned at the 

beginning of the call. That in some cases the disk brands are not during the 

drug trial, and therefore there is no data associated with that particular brand. 

And we have had interactions and have made recommendations to 

manufacturers about how to go about doing that. In those situations, the data 

is actually reviewed at CDRH, not at (CDER) as would be the case with an 

NDA and any special information about specifics of the drug can be shared. 

Now I’m going to activities to date. Many activities have happened. At the 

beginning of the call we talked about the 2016 where we have the in the draft 

guidance. And we have one piece of mission at that time. 

And it moved from left to right. You will see that at that time, the timeline 

between a drug approval to device clearance, has been taking upwards of like 

14 months. So, 14 months have gone by for some devices to become 

available for a second drug from day zero of the drug approval. In 2017 we 

had six piece submission and we had nine just in case, that were submitted. 

Some of them have come in under a pre-submission for development. Some 

have were already coordinated between the without necessary presubmission . 
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In other words, they conducted the studies earlier so that they can bring the 

submission through CDRH area. Examples of growth are their success and . 

And so, a review against the (CDER) drug approval for device, have been 

short and in some cases for one to two months. So, we are producing in 2018 

sort of repeating some story and we had more devices, so more drugs 

available to patients in an area . 

So, this slide appropriately, slide 27, this is the graphic. Appropriately this 

should be the before and after, not just after. Because a picture is worth 1000 

words, in this case the bottom half of this slide, the four bars that have blue; 

remember at the beginning of the call I said blue bad, well all blue is bad so 

you see that for these four devices have taken this long in order for them to 

become available. 

And all of it depends on when was submission coming in the end, after drug 

approval? So, during the blue bar period, that’s the period where the device 

manufacturers were actually doing the study, so that they can submit to 

CDRH. With coordinated development and with efforts that are taking place 

earlier than later, we have a case where - we have many cases now, but what’s 

shown on this slide, is three devices were cleared between 33 to 41 days after 

receipt and in 44 days after drug approval. 

In fact, I can ad lib here and say that in one of these cases we were called by 

the device manufacturer, saying that actually where the device clears and still,

they’re making the drug for distribution to the field. So, and they’re an 

excellent case where they had the devices, so they’re still distributing the drug 

to the field. I mentioned in a couple of places where there are other initiatives 

that are add on ways by which FDA and others including in this case CDC, 

can help availability of certain organisms, such that if they are needed for selfevaluation, they are available. 
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And for example, we have the FDA CDC bank or call CDC FDA AR bank. 

Then as we know, not necessarily tells us what they have used, but today we 

know that it is the on this bank, has contributed to clearances and approvals 

for AST devices on other - and other infectious disease deaths that were 

submitted since its launch of 2015. 

The the slide has the and people actually with that and how it has facilitated 

the availability in a streamlined manner, of the susceptibility breakpoint in an 

easy way, so that people can be having that information rather than digging 

into the drug labels. And Dr. (John Flatley) here, is with me, in case there are 

any questions about that, that we think that those advancements, as well as 

other advancements, not necessarily on this slide, have really contributed to 

the success and we hope that will consider to contribute to the success of 

coordinated development. 

And so finally, end with the benefits to public health. Obviously earlier 

availability of diversity of AST devices, do help in improving patient care. 

We think that they will contribute or can contribute to antimicrobial , by 

having susceptibility available and needed for testing. Include their ability to 

monitor for any (imaging) resistance isolate, and will get flexibility in drug 

testing and reporting with our how devices are labeled. And we have seen a 

device update and labeling as well. 

And with that, I will end with some resources and links to important guidance 

documents and resources. The AST Special guidance, which pretty much 

governs many of the (review) for AST devices, according to development 

guidance obviously and the docket in case anybody wants to connect to that. 

And the CDC and FDA antimicrobial and finally, the . And with that, I will 

turn it into Irene. Do we have questions? I’ll turn it back to Irene. 
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Irene Aihie: We’ll now take questions. 

Coordinator: Thank you. To ask a question, please press star followed by 1. Please insure 

your phone is unmuted and record your name clearly when promoted. Again, 

that is star followed by 1 to ask a question. To withdraw your question, press 

star 2. Again, we would like to remind all parties that we will take one 

question at a time. And if you would like to ask a follow up question, to 

please re-queue. One moment, while we wait for parties to call in. 

Irene Aihie: So, while we’re waiting on participants to ask questions, I believe (Ribhi) has 

some questions or some comments that he would like to make. 

Dr. (Ribhi Shawar): Thank you, Irene. Yes. For example, we’ve received some questions 

beforehand. And while people are thinking of questions, don’t think too hard, 

so for example, can FDA clearance in a AST device together as one package? 

And the answer to this one is no, as I said in several places, I think, I hope. 

The drug approval is separate from device clearance and they remain to be 

separate. Those questions I think I also might have answered those as well. 

How many antimicrobial susceptibility tests have been cleared under the 

development? 

I have the data as of the end of 2018 and 13 devices have been cleared through 

their coordinated development process. I don’t have any other questions at 

this point. 

Irene Aihie: Operator, are there any questions? 
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Coordinator: At this time, we have no questions. Again, if you would like to ask a 

question, to press star 1. One moment. (Sharon Cullen), your line is open. 

You may ask your question. 

(Sharon Cullen): Hi (Ribhi). Thanks for the presentation. This was great. I have a question 

about the (510K) submission and the timing of the NDA. So, if we submit the 

(510K) and it takes a little bit longer on the NDA, will you simply just put that 

submission on hold to coordinate then that timing? 

Dr. (Ribhi Shawar): Yes, thank you (Sharon). That’s a good question. It will depend 

obviously on the timing and how close it is. And we will not be doing 

anything without interaction with the sponsors. It is possible that something 

could be placed on hold and that would not be really our ideal. And that’s 

why the ideal would be to - if people can predict the future, is to time it so that 

the timing of the drug approval will be in - within the timeframe of the review 

of the (510K), so that when the drug gets approved an action can be taken on 

the device. 

The main point here is that we cannot - CDRH cannot take an action on 

clearance of a device, until there is a drug that is marketed in the US or that is 

approved in the US. 

Coordinator: Thank. (Michelle Tamory), your line is open. 

(Michelle Tamory): Yes, hi. I just wanted to find out what are some examples of devices and 

drugs that would need to be coordinated in terms of, you know, both sides 

CDRH as well. So, what would be a pair where there would need to be 

coordination; an example of this please? 
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Dr. (Ribhi Shawar): If I understand the question, for example there’s one slide that I showed 

different antimicrobial agents that have - were under consideration for 

approval by either, and various device manufacturers were interested in 

having an AST device available for those. So, those are examples of the type 

of drugs that are suitable for coordinating development. Really, in reality, any 

antimicrobial agent for which there will be a commercially available AST 

device, are and ought to be . 

I’ll try and turn this maybe to Dr. John Farley from (CDER). Maybe he’ll be 

able to add something else. 

Dr. (John Farley): Yes. This is (John Farley). Thanks for that question. So, I think what we’ve 

worked hard to do over the last couple of years, and I think as a community, 

we should be pretty happy with these results, is to be sure that when a new 

molecular entity, antibacterial drug, is approved, that laboratory scientists 

have a tool in their lab, to assess susceptibility. 

So, it’s - so our priority has been new molecular entity antibacterial drugs in 

terms of this coordinated development program. Folks on the phone think that 

there are another group that we’re missing, you know, please let us know. But 

we think that devices generally are available for previously approved 

antibacterial drugs. 

(Michelle Tamory): Okay. Thank you very much. 

Coordinator: Thank you. Again, if you would like to ask a question, please press star 

followed by the 1. 

Irene Aihie: Thank you. This - thank you. Operator, do we have any other questions? 
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Coordinator: We do have one final question from (Andy Pracchia). Your line is open. 

(Andy Pracchia): Yes. It’s actually a question just for CDRH I guess. If you have a drug that’ 

sunder (Sieber), do you know if this program would also apply? 

Dr. (Ribhi Shawar): I do not know that it would apply, but maybe with more specifics may be 

able to have the better answer. For CBER it is going to be like a biologic of 

some sort. Yes? 

(Andy Pracchia): Yes. It’s a biologic, but it’s categorized of a drug under (CBER). 

Dr. (John Farley): Yes. This is (John Flatley). I can probably take that. So, I think the three 

centers have been working together very well on a whole lot of different 

issues. We haven’t thought of that and I’m actually really glad that you 

brought that up. We had a workshop earlier in the year on sort of 

nontraditional antibacterial drug therapies. So, I’m actually really glad you 

brought that up. 

So, we’ll talk with the (Sieber) folks should that situation arise down the road, 

but I think that the principles that have been established through this process, 

could certainly apply. 

(Andy Pracchia): Great. Thank you. 

Coordinator: Thank you. At this time, I will now turn the call back over to Ms. Aihie. 

Irene Aihie: Thank you. This is Irene Aihie. We appreciate your participation and 

thoughtful questions. Today’s presentation and transcript, will be made 

available on the CDRH Web page at www.FDA.gov/Training/CDRHLearn 

by Wednesday, February 20. If you have additional questions about today’s 
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Moderator: Irene Aihie

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presentation, please use the contact information provided at the end of the 

slide presentation. As always, we appreciate your feedback. 

Following the conclusion of today’s webinar, please complete a short, 13 

question survey, about your FDA CDRH webinar experience. This survey 

can be found at www.FDA.gov/CDRHWebinar, immediately following the 

conclusion of today’s live webinar. Again, thank you for participating. This 

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END