NHLBI Small Biz Hangouts: Conquering the (Regulatory) Basics | Navigating the FDA Website


Good afternoon,
and welcome to the first in a series of NHLBI
small business hangouts. My name is Eric Padmore,
and I will be the moderator for this afternoon’s
presentation. The NHLBI Office of Translational Alliances
and Coordination has developed this
series to help educate our small business
applicants and awardees on topics
that will be helpful to their business
and research enterprises. Today’s presentation
will focus on FDA regulatory
information. If you are watching through a Google+
Hangout account, you can submit questions throughout the presentation by commenting
on the Hangout event page. If you are watching
on YouTube, you can submit questions
via Twitter using the hashtag
#sbirchat, all one string. I will be
moderating questions, and we will be
answering those at the conclusion of each segment
of the Hangout. Today’s presenter is
Dr. Chris Sasiela. Dr. Sasiela
earned her doctorate in pharmaceutical sciences from the University
of Maryland School of Pharmacy. After postdoctoral studies at the National Cancer
Institute, she was awarded
a fellowship to work at the FDA and learned
the regulator’s perspective on product safety review. She completed her fellowship at the Center for Drug
Evaluation and Research’s Division of Monoclonal
Antibodies. After her fellowship, Chris joined the NHLBI
after leading a regulatory affairs
and services team in private industry
for several years. Within the NHLBI,
Chris serves as a regulatory resource for the Institute’s
small business awardees and for investigators who are developing
or performing clinical investigations using new technologies. Today, Dr. Sasiela
will be presenting an overview
of the FDA website, providing search tips,
and making us aware of a number of
resources available to assist
small businesses in developing
their technologies. Welcome, Chris. SASIELA: Thank you, Eric, and welcome
to our audience today on this Google+ Hangout. I’m going to switch over
to a slide deck, and then we’re going to go
directly into navigating the website. So, as Eric mentioned,
this is the first Small Biz Hangout that our
office has coordinated, and our topic today
is going to be “Navigating the FDA Website.” Why Navigating the FDA Website? Last year, in my role
as a regulatory strategist within the NHLBI, I worked with approximately 70 to 80 small business concerns in terms of counseling them in their regulatory strategy and understanding the pathways that they would need to follow in order to begin their regulatory clearance or approval processes. And I discovered that there were a number of common questions
that came up with small businesses. And what I’d like to try
and accomplish today is to address two of those. The first is, “What resources
do you as a small business have access to to help inform
your technology development?” And then the second question is,
“Who can you talk to at FDA?” So the learning objectives for
today’s seminar are going to be to be aware of
and able to identify the reference documents that can
inform your product development, the small business resources that the biomedical Centers
at FDA have developed — and just as a reminder, there are three
biomedical Centers — the Center for Biologics
Evaluation and Research, the Center for Drug Evaluation
and Research, and the Center for Devices
and Radiologic Health. And then also helping you
identify where you can find the organizational charts
for the biomedical Centers, so that you can identify
reviewers who might be engaged in the regulation
of your specific product. And offices that FDA
has established to address specific
development areas that don’t fit within
one concrete Center. And then finally we’re going to
go back to the FDA home page and take a look
at how to sign up for relevant FDA updates, including information
about guidance documents, upcoming public meetings,
workshops, and meetings that FDA
may be coming to in your geographic area, so that you can have one-on-one
personal contact with FDA staff. So, with that,
I’m going to now switch over to the live website
demonstration. So the home page for the FDA
is www.fda.gov, and this is what the home page
looks like, and you’ll see
that it is organized in a very user-friendly manner, and yet there’s so much
information that it can be hard to identify
exactly what you’re looking for. If you want to understand more
about the regulation for food, drugs,
medical devices, or radiation-emitting products. As you can see, there are
some tabs across the top here that are useful to get you
to broad category areas. If you’re looking something a little more specific
and concrete, if you look up
at the upper-right-hand side of the screen,
you’ll see a search bar. We’ll be using that
extensively today, as it’s a very useful way
to find information on the FDA website. I have found in my experience that bookmarking pages can be
a little bit tricky, because FDA occasionally does
reorganize their website. And so it’s easier to just do
a quick search, as long as you understand what search terms
you want to use. If you just want to investigate
the home page, then you’ll notice over here
on the right-hand side, there are four sort of broad
research areas. And down here,
the fourth one down, with the little gear on it,
says, “For Industry.” If you were to click
on that link, you would find that there are a number of broad industry
resources available to you. So let’s take just a little bit
more of a look at the home page by scrolling down. These — this carousel up here normally rotates between
a number of different stories that are of broad general
interest to the public but usually are not of specific
interest to industry, For industry-specific
information, you might be interested in
recalls and alerts, approvals and clearances, or reporting a problem. FDA wants you to know
about the different initiatives that they have going on, so they
keep those front and center on the home page,
very easy to find. News & Events — if there are
recent recalls or problems with devices or therapeutics
that have been out there, or food issues,
drug shortages, that sort of information
will come into News & Events. And then at the bottom
of the page, you’ll find general information
about FDA, ways to follow FDA — we’ll be coming back to this
in a little bit — and some general background
information about the regulatory agency
itself. So, as I mentioned earlier,
many small businesses don’t really have
any experience with or knowledge of how FDA works and where to find
either basic information about the regulatory process or specific information to inform their
product-development work. So each Center within FDA has
developed a set of resources to help the public and industry
understand how they operate. They call these resources
their Learn series, and what I want to do is
I want to come up here to the Search FDA box, and I’m going to type in
“Learn” and then I’m going to put in
the CBER, which is the abbreviation for the Center for Biologics
Evaluation and Research. So when you come to — when you
come to this top bar, the top return says,
“OCTGT Learn,” and this is the Office of Cellular Tissue
and Gene Therapies, within the Center for Biologics. This is the primary site
for the Biologics Learn series. And when you come to this site, you’ll see
there’s a course list. And if you scroll through,
you’ll see there’s quite a variety of areas
that you can learn about — everything from the regulatory
obligations for investigators to IND safety recording, IND basics in this particular
office, and sponsor meetings
that you can have. So it’s a very comprehensive
list, and as you click through, you’ll see that there’s additional information
available. We just reviewed
the Center for Biologics. We’re going to go ahead and look at the Center for Drugs’
Learn pages. And again, you’ll see that the Learn page resource
is at the top of the returns. Here the course list looks
a little bit more abbreviated, but again, as I mentioned
earlier, if you click through
these links — and that’s what I’m going to do
right here for CDER World — you get a much more
comprehensive view of the types of lessons
that the Center for Drugs has developed to inform
their audience. And finally, I want
to take a look at CDRH Learn. And when we come here,
you’ll notice that for the Center for Devices
and Radiologic Health, that they have actually
developed courses not only in English, but also
in Chinese and Spanish, and although these are not
certified translations, they are the best effort
that FDA has put forth, and I’ve heard very positive
feedback from users that they are very useful. Let’s take a look here at some of the courses
that are available. The overview
of regulatory requirements for medical devices is a very, very useful resource
for small businesses. And I am going to open this up
and show you that once you expand that,
you really get a much more comprehensive list
of courses, videos, printable slide sets, and they cover a wide variety
of topics, including recently issued
guidance documents and the presentations that FDA
staff have given for those. Premarket notification
process — the 510(k) process has
quite a number of presentations. You can get many of your basic
questions answered in these by viewing these series, and then of course
the IDE process, the medical device recalls,
quality systems, and of particular interest to a number of small businesses
that are popping up these days is CDRH-regulated software, so that you can understand
the integration of software into your product development
needs and processes. So that is my review of the CD–
of the FDA’s Learn websites. But the Learn websites, as wonderful a resource
as they are, may not give you information
that is specific enough to inform
your product development. And to address this,
what FDA has developed are a very extensive series
of guidance documents. Guidance documents from the FDA describe the agency’s current
thinking on a topic, and so if you are developing
a product, you may want to see if there are
any guidance documents about it. As Eric mentioned
during the introduction, I did some of my work at FDA within the Division of
Monoclonal Antibodies, so what I am going to put
in here is, I’m going to type in “guidance”
and “monoclonal antibodies.” And when we run that search, you’ll see that there are
1,260 hits on the total FDA website that say “guidance,”
“monoclonal antibodies,” that include those terms. And so that was a very general
search term — what you might want to do is either peruse the complete list
of guidance documents, if you have that time, or you may want to narrow your
search a little bit more for guidance monoclonal antibody chemistry and manufacturing
controls, for instance, And that would bring up
a narrower subset. Your search string
in that box can be as precise
as you want it to be. So, in addition
to the Learn pages and the guidance documents
that you can search for, these resources really offer
fairly general information. Through the Freedom
of Information Act, each Center posts information
about products that they either clear
or approve for marketing. And small businesses — I always
encourage a small business to take a look at these types
of documents, because you can learn a lot
from them. They provide insights
into the types of testing that other businesses are
providing to FDA to demonstrate safety
of their products. They provide information about how clinical data
is analyzed statistically, the types of clinical data
that may be provided to support efficacy claims, and additionally, through these
what FDA calls “Reading Rooms,” you can, for medical devices
in particular, see the iterative development for consecutive generations
of a product. So, instead of going through
this for every Center, what I’m going to do today is, I’m going to look
only at the Reading Room for the Center for Devices
and Radiologic Health. But please trust me
that the sites do exist for all three Centers. So, as I mentioned,
FDA calls these environments their Reading Rooms. And by searching
“CDRH Reading Room,” the top hit will bring us
where we want to go. And from here, the way
that CDRH organizes things is that they have the primary
resource of the Reading Room, and then they’ll let you know what are their most
recently posted documents. So if you’re looking for
something that was approved in the last week or two weeks,
often it will appear here in
the Newly Posted Documents. So we’re going to move forward into the Electronic
Reading Room. And I want to draw your
attention here to this sidebar section
on the right that says, “Other Databases.” So you could try and search
in here from this page, but you might get
many more returns than you would otherwise
anticipate. So what I try to encourage
companies to do is to identify products that may
be similar in one way or another to the product — the technology
that they are developing, and for the Center for Devices,
you can reach market approval through a premarket
authorization, so premarket approval, or you can reach market
clearance through the 510(k) pathway. And I want to take you just kind of quickly through
both of these. So we’re going to start
with the PMAs, And when you get to this page,
you see “Search Database,” and there are many different
fields that you can complete in order to perform your search. Often, most of this information is going to be unknown
to a small business. And so you might know,
for instance, the trade name or the brand name
of a device that you’re going to be
referencing. And in my case, coming from
Heart, Lung, and Blood, I’m going to choose a device
that was recently approved by the trade name MitraClip. And if you search
using just the trade name, no other information, you will see
that there are two returns, so there’s the original approval
and then a more recent approval. Going to the original approval will often yield
the most expansive information. Iterative Development
is a way to learn about what a company is doing
to improve their product, but often doesn’t include
the comprehensive amount of information that you will see
in the original approval. So let’s click through
this original approval, and if we come down here to “Information
about this Product,” you can see the labeling,
approval order, and summary of safety
and effectiveness. I’m going to open this up, and
I’m going to open the summary. And I’m going to reduce the size
of this just a little bit so that you can see more
comprehensively what is going on
on the screen. And you can see here
that there is a lot of general information
about the device; its indications for use; contraindications,
warnings, and precautions; a device description, which often includes one or more either graphics, blueprints,
or pictures. There are dimensional
information, there are how to use the device, practices, places where it may
be marketed, adverse effects,
preclinical studies, biocompatibility information
and testing, sterility testing,
animal studies, shelf life studies. This sort of information
can help a small business really understand the extent
of testing that FDA requires for a 510(k) submission. And understanding what your
competitors have needed to — or your predicate companies
have needed to do to prove their efficacy to FDA is often very informative
for you as you develop
your go-to-market plan. So now I’m going to close down
that page, and I’m going to go back
to the Reading Room, and instead
of the premarket approvals, I’m going to go to the 510(k)s. So, for the premarket approval, I went ahead and I put in
the device name, which is what it would be called
on this page. However, for the 510(k), you may not know what the exact
brand name is of the device that you believe
is a predicate, but you may know of a company
that is doing research similar to what you are doing. So I am going to pick on another heart, lung, and blood-focused
company, AliveCor, and AliveCor develops
heart monitors, and you can see that their first
approval was in November of 2012 with a heart monitor that was
part of an iPhone case, and then in iterative
development, they’ve gone ahead and submitted just a heart monitor unrelated
to a specific technology, and then they recently developed
an over-the-counter version. So again, the documents that we
would be able to pull up for this particular technology would be just as extensive
and comprehensive as the information that we
pulled up for the PMA, the only difference being
that there would be less clinical efficacy data
involved. At this point,
I have covered the — how to find information
on the FDA website through
the Freedom of Information Act, through the Learn series, and through searching
for guidance documents. And so, Eric, I’d like to know, has anyone asked
any questions yet? PADMORE: So,
at this point, Chris, we do not have
any questions. I would just like
to remind our viewers that throughout
the presentation, you can post
your questions if you are watching
through a Google+ account on the Hangout event page by just putting your comments in the Comments section. And if you are
watching via YouTube, again,
please use Twitter and use the hashtag
#sbirchat to post
your questions, and we will take those and relay those
to Chris. Seeing no questions
at the moment, then, Chris, back to you, and continue on
with our presentation. Thank you very much,
Eric. So, back at our home page,
our FDA home page, let’s take a look. Now that you understand how to
find this basic information for FDA’s regulation of your
biomedical technologies and you have some general
product development information through the Freedom of
Information Act Reading Rooms, You may be thinking
that you’re ready to prepare your IND or your IDE
or your 510(k) submission. And, although it is true that
there are some companies that can submit to the FDA without any prior contact with
the agency itself, in reality,
for most small businesses, this probably isn’t
the best approach. So how do you identify
a specific person at FDA who can help you answer
questions that are specific
to your technology? A good way to start this is
by reaching out to the Small Business Office
at the appropriate Center. And if we come here
to our home page and we come to this
“For Industry” section that I pointed out earlier, let’s click through on that. In the “For Industry” section,
you’ll notice that, in addition to different information on
the carousel, there is this “Navigate the For Industry
Section” that comes
right below the carousel. At the very top
of the right-hand side of this is “Small Business Assistance,”
and that’s really a great place
to start. So, as we click through there,
you’ll see it brings you to a small blurb about
the small business assistance that FDA
generally offers. And then, over here
on the left-hand side, there are two hyperlinks. One is the Small Business Guide
to FDA, which is a useful document
to take a look at. It provides some basic overview of FDA regulation
and inspections and how to interact with FDA
for small businesses. And another useful part
of the information in there is that it provides
small business contacts. However, for today, instead of
going through the guide, we’re simply going to click
through the Small Business Contacts
link. And as you take a look at this,
you’ll see that each Center — the Center for Biologics,
for Drugs, for Devices, for Food Safety,
Tobacco, Veterinary,
and International Programs — each has a contact,
and the contact information will include an e-mail address where you can address
your questions. It will also provide
both a local phone number, if you happen to be in
the Maryland-D.C.-Virginia area, And an 800 —
or a toll-free number for both domestic
and international callers. So another thing that’s very
common within small businesses is that small businesses
may be developing a platform technology. And if that describes
your company, you may have already developed a preliminary relationship
with FDA, related to your first indication
for use for your technology. However, you may be now moving
into a new area that would be regulated
by a different part of FDA or a different division or
branch within the same Center. And at this point,
you’re somewhat comfortable with the types of information
you’re going to need, but you want to talk to someone
in that particular division to make sure that you understand
their specific requirements, the questions
that are more important to that branch
or that division. In cases like this, it’s really
useful to just pick up the phone or to send an e-mail to your
target review division. And the best way to do this
is to identify who is the appropriate division director
or branch chief and reach out to them. On the FDA website,
using my favorite — the search box up here
in the corner — you can look up
contact information. And as we’ve been —
as I’ve been mentioning thus far throughout the Hangout,
FDA is broken out into Centers. So underneath the Center level, the Center for Drug Evaluation
and Research, are Offices and Divisions. As long as you understand that
the next level down is Offices, you will be able to find,
searching by the Center CBER, then just type in “office,”
and your top link will come up with CBER Offices and Divisions. You may not be 100% certain
where within the Center your product
is going to be reviewed, and so if you come to
the CBER Key Staff Directory and you open that up —
pardon me — you’ll see that
the Key Staff Directory is broken down by office,
and then within that, by the directors and the —
let me get to a somewhat more — the Office
of the Center Director is often a little more rife
with people. But the Office for Biostatistics
has a Division of Biostatistics, which has a vaccine evaluation
branch, a therapeutics evaluation
branch, et cetera, et cetera. And so, if you are developing
a new blood product, the Director for the Office
of Blood Research and Review would be Dr. Epstein. But you may be developing
a specific technology that is looking
for a hematological signal or targeting
a hematologic disease, at which point you would want
to address your questions about your technology
to Dr. Basil Golding in the Division of Hematology. And as you can see, there is
a phone number provided here, and you can simply
pick up the phone and call. This same sort of search works for each of the other Centers
within FDA also, and so for the CDER
Offices and Division, the return is a little bit
different — you don’t have to go through
that Key Staff website — it brings you directly to the breakdown
by Office and Division. And if you wanted
to be developing a product for a cardiovascular
or renal product, you would simply click
on the Division of Cardiovascular and Renal
Products, and when you were connected
through, you would find that the name of the chief of the division
would show up, so the Director,
Dr. Norman Stockbridge; Deputy Director, the Chief of
the Project Management Staff, and the mailing address,
phone number, and fax number would be right here. Again, the same thing
would hold true if we were looking
for the CDRH contacts. So, in addition
to the Center review teams, which is what we
have just been identifying — which Center — who are
the staff in the Division who would be reviewing
your specific technology — you may be developing
a technology that hits more than one Center, so you may be developing
a combination product. FDA has recognized that there
are a number of areas that cross centers, where there
needs to be a cohesive policy for the regulation of products
in those areas, and those three areas where the FDA has developed
cohesive offices at the Office of
the Commissioner level are Combination Products,
Orphan Products, and Pediatric Therapeutics. And so, if you were —
if your company is developing
a combination product, again, using the search bar,
you would find that the top return
for a combination product brings you right here to the
Combination Products home page, and if you scroll down,
you would contact someone in the Office
of Combination Products. You could either send
a snail mail, an e-mail, or make a phone call
or send a fax. The contact information
is right there. The same holds true if you are
developing orphan products, with the slight caveat being that for this page, there are quite a number of
additional programs that you can find out about,
including the voucher program for rare pediatric diseases and the Orphan Products Grants
Program, which are often very helpful in identifying…
additional resources to support your research. The contact information for the Orphan Products
Development program again is down at
the bottom right of the page. And each of these people’s
names, if you click on it, would lead to open
an e-mail message within your browser,
where you could just e-mail the person directly. And the final group that I mentioned is Pediatric Therapies. And…huh, that didn’t seem
to work very well, did it? Let’s try something else. Again, as I mentioned earlier, you need to be
sometimes creative in the way that you search. So let’s go to
Pediatric Products — well, there you go,
Pediatric Product Development. And in this case, you don’t see
a contact information on the lower right-hand side,
but you do see a lot of information
about pediatric development and the various regulations
that have been involved. In this case,
where you need to come to find
a specific contact person is under the Resources for You and Pediatric Therapeutics. So if you come to
the Pediatric Therapeutics page, down at the bottom, again, you’ll find
the contact information for both the office by e-mail
and a phone number. Eric, I’m going to throw this
back to you and ask if there are any
questions at this point about identifying contact
information within the FDA. PADMORE: So, Chris,
we do have one question, which actually
harks back to the earlier part
of your presentation, which is, “Is there
a guide or a flow chart that outlines
all the requirements for approval,
and if so, where could that
be found?” That’s a great question,
and unfortunately, I think I need to bounce back to
the person asking the question, because I would need
to understand more about the type of technology
that they’re asking about. Are you asking
about a drug, a biologic, a medical device,
an in vitro diagnostic? In some cases,
there actually are flow charts that can help you
understand how your product
will be regulated, and in some cases,
for instance, with the 510(k), there is a checklist
to ensure that you have
all the parts and pieces that FDA expects to see. However, in terms
of which specific tests are required for each
specific technology, that information does change from one technology
or therapy to another. Are there any
other questions, Eric? PADMORE:
Not at the moment. SASIELA:
Okay, so, then, now that you understand
all of the great information that is available
on the FDA website, let’s come back
to the FDA website and… find out how to stay current on the information
that they do have to offer. We’re going to come back
to the home screen, and we’re going to scroll down
over here to the “Follow FDA” section. My personal preference is to
receive information by e-mail. If you have a different
preference, where you prefer
to follow a Twitter stream or sign up for RSS feeds, much of this process
is going to be the same. But I’m going to start by
signing up for e-mail updates. So FDA can update you
on any number of topics, and they really are very good
about pushing information out the way that you want to see it, so that you will receive only
that information that is of value to you. So, for today, I am going to
sign up for Biologics. And I want to get information
on blood guidance documents that may be released in either
draft or final form. So, in order
to sign up for this, I need to put in
my e-mail address. And then submit. And I can identify now… How I’d like to receive
my information. Do I want to receive information
as soon as FDA posts it? Do I want to get a daily update? Or do I want to get
a weekly update? So I’m not all that concerned
about getting an e-mail immediately or every day, but I
would like to know each week what new guidance documents have been submitted or released
by FDA. So I’m going to submit that. And I’m going to then say, “Well, but that wasn’t the only
thing I wanted to know about,” and so I’m going to, instead of
finishing my sign-up, I’m going to go back to
“Subscriber Preferences.” And I’m going to add some
additional subscriptions. So, in addition
to blood guidances, I would like to know about
general CBER guidances, about any recalls that may be
coming through, and tissue guidances,
vaccine guidances, and I’d like to know
if there are any workshops and conferences
that may be of interest to either myself
or my small business community, so that I can make them
aware of that. And in addition,
perhaps I also want to find out some information about drugs. So I want definitely to know
what’s going on with small business and industry
assistance, and I think
it would be very important for me to know what is going on
with drug safety news, because that is something
that I hold very important. So now I can go ahead and submit
my additional alert preferences. And you’ll see
up at the top of the screen that my subscriptions
have been updated and I will be receiving
an e-mail once per week about this, and they also offer me
the opportunity to get information from
additional sources, such as the National Institutes
of Health, the Centers for Disease Control, the Department of Health
and Human Services, et cetera. And so, if you find that there
are additional places where you would like to get
information, then you can go ahead
and sign up at the same time. And I am now going to close down
this sign-up, and I’m going to ask
one more time, Eric, have we received any additional
questions based upon how to request
updated information from FDA? PADMORE: Well, yes, Chris, they are coming fast
and furious now, so just as a follow-up
to our previous question about the availability
of flow charts, the questioner
was asking specifically with respect
to medical devices. Okay, thank you very much. So, as I mentioned,
for medical devices, if you are developing
a product that can be cleared
using the 510(k) process, then there is
a 510(k) checklist that you can use,
and let’s come over here, and I will try and do
a live search for that. So we’ll just type in “510(k) checklist.” And what we identify is that there is a cover-sheet
checklist for 510(k) acceptance, and there is
a “refuse to accept” policy for 510(k)s, and this is
one of those guidance documents that I mentioned earlier. And so, between the information
on these two documents, the questioner
should be able to find much of the information
they need to identify if their submission
is complete. However, in order to identify if their submission contains
the appropriate information, they should both do the research of identifying appropriate
predicate devices and looking through
their
approval summaries, and they should contact FDA to
ensure that their submission is as complete as the FDA
would like to see it in advance of filing. And that can be done through
relatively informal processes, such as an e-mail
or a phone call, or it can be done
through a more formal pre-submission meeting process that FDA offers
to its industry colleagues. Do we have additional
questions, Eric? PADMORE: So, Chris, with respect
to the 510(k) process, is there
a guidance document for design control
for the device that is
being developed? Thank you, Eric. There may be design controls, or “special controls,”
as they are called, for specific devices. So if I were looking
to develop a device, let me suggest a… some sort of device, what sort of device? A spirometer… Which is a device that
you may familiar with if you’ve ever been in a hospital
and undergone surgery. After your surgery, you’re asked
to breathe into this tube that measures how much volume
your lungs are putting out. So I’m going to type in “spirometer,”
“special controls,” “guidance.” And I do not know the answer
to the question of whether there are or not,
but look, there is indeed a special controls
guidance for… breath something
[Chuckles] that we will hopefully
open up in a moment. And this special controls
guidance document should guide you through
what FDA expects to see in a 510(k) submission for
a well-characterized device. Apparently,
my Internet connection is a little bit slow
in loading. And…I may or may not actually be sharing my screen
at the moment. There we go,
I am sharing the screen. And let’s see if we get to that. So this is — this particular
special controls document deals with breath
nitric oxide test system. So this would not necessarily be
the appropriate control specifically for a spirometer, but if we were to go back
to the original search page, the return of the search page, we might find the more
appropriate guidance document. Do we have additional questions,
Eric? PADMORE: Chris, one of
our viewers wants to know, is there a way to find out about clinical trials, procedures, and results,
et cetera, of products that are
similar to the one that
the small business is currently
developing? That is a great question, and the answer is,
“Sometimes.” So it depends how the…company has presented their information. Through the… through the clinicaltrials.gov
website… You will see — or if you’ve ever gone onto
clinicaltrials.gov — let’s just let that return the appropriate — The clinicaltrials.gov protocol
registration system is a mandated registration for companies developing
FDA-regulated products within the U.S.
for phase 2 and greater studies, and you will often find some information about protocols
through this website. Sorry, I clicked
the wrong link. Let me go back.
Here we go. Through the home site. So if you wanted to search,
for example, as they have here,
heart attack in Los Angeles, it would return a series of
clinical trials going on in that area —
in that geographic area and that indication. Additionally, it would put out
not just what is current, but what is upcoming
and what is closed out, and post-recruiting
post-analysis. And at the end of any clinical
trial, the sponsor is required to post some summary
of the results on this website. Additionally, if you go into the summary
of safety and efficacy or a 510(k) or a biologic
or a PMA, then there is also information
in there about both the clinical
protocols as they were run, although it won’t be as complete
a design standard as a full protocol would be, and there is information about
the proof that the sponsor provided to FDA
to ensure either superiority
or noninferiority or efficacy
in a new indication. And since we already
reviewed those websites, I will not go back and look
through those again. Do we have additional
questions, Eric? PADMORE:
Chris, those are all the questions
we have at this time. SASIELA: Okay,
well, then, I want to say, “Thank you,”
to our audience for joining us today,
and so, as we — we did review a number of websites
of general interest, including the FDA Home page, the FDA Small Business Guide, the FDA Small Business Contacts, and the FDA Information update
request page. We also went to
the Electronic Reading Rooms that were created in the Freedom
of Information Act. Some of the information will be
redacted on those pages, but by far
the vast majority of information that small businesses can learn
by reviewing those documents is quite valuable. And we visited the pages for
both the Center for Biologics, Center for Drugs, and Center for
Devices and Radiologic Health. We also reviewed how to search
for guidance documents. We went to the contact pages to identify division and branch
contacts for the Center for Biologics,
Center for Drugs, and Center for Devices
and Radiologic Health. We looked at the pan-FDA
area of interest offices — the Office of Combination
Products, the Office of Orphan Drug
Products, and the Office
of Pediatric Therapeutics. I hope that you have found
today’s presentation to be useful and informative, and I’d like to share with you some upcoming future regulatory
basic Hangouts that we have planned. In June, we will be discussing
“first contact” with FDA — how to make
that initial contact, how to know who to send
your paperwork to, where to submit it, and what the types
of first contact might be, from a request for designation
for a combination product through a pre-submission meeting
or a pre-IND meeting with respective Centers. In September, we will be
providing an overview of medical device classification
and regulation. And in December, we will be
providing an overview of drug and biologics
regulation. I hope that you have enjoyed
today’s Hangout, and I thank you very much for
your attendance today. If there are no final questions,
or perhaps if there are — Eric, back to you. PADMORE: No final
questions at this point, but do join us again. You can follow us
on Twitter @nhlbi[underscore]sbir or our general
Twitter account, which is
nih[underscore]nhlbi. And also follow us
on YouTube just by
searching NHLBI. Over to you, Chris. And thanks to all
of our viewers. So this completes today’s
regulatory Hangout, and I do hope
that you have found this to be useful
and informative. If you are developing
technologies within NHLBI mission space,
please do contact us. If you are developing
products or technologies that fall outside
of our mission space, please contact one of our
sister institutes or centers here at the NIH or use the information
that you learned during today’s Hangout to contact the appropriate
review divisions within the Food and Drug
Administration. Thank you very much.

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