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Postmarketing Study Commitments
Frequently Asked Questions (FAQ)
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Why is FDA providing this
Web site?
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What information does the
Postmarketing Study Commitments Web site include?
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Where does the information on this
site come from?
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How often will the Web site be
updated?
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Can a product have more than one
commitment related to it?
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Does CDER require applicants to submit
an annual report?
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Does CBER require applicants to submit
an annual report?
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When and how often must an applicant
submit an annual status report to FDA?
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How soon will information from the
latest annual status report appear on the Web site?
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How can I search the Postmarketing
Study Commitment database?
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What will I see in my search results?
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What is meant by "Commitment Required
Under: Accelerated Approval" in the search results display?
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What is meant by "Commitment Required
Under: Animal Efficacy Rule" in the search results display?
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What is meant by "Commitment Required
Under: Pediatric Research Equity Act" in the search results display?
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Why do some products have an
"Original Projected Completion Date" while others do not?
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What do brackets [ ] mean in the text
of the commitments?
-
Does the site include an explanation
of the status for a particular commitment?
-
What do the "Commitment Status"
categories mean?
-
How can I get a copy of a
postmarketing study commitment protocol or final report?
-
How can I download a data file
containing the information displayed on this Web site?
-
Whom can I contact if I have more
questions?
1. Why is
FDA providing this Web site?
Section 130(a) of Title I of the Food and Drug
Administration Modernization Act of 1997 ("the Modernization Act")
became law on November 21, 1997, and added section 506B (Reports of
Postmarketing Studies) to the Federal Food, Drug, and Cosmetic Act
("the Act") (21 U.S.C. 356b). This provision requires sponsors to
report to FDA annually on the progress of postmarketing study
commitments. FDA uses postmarketing study results to gather additional
information about a product's safety, efficacy, or optimal use. back
to FAQ list
2. What information
does the Postmarketing Study Commitments Web site include?
The site includes postmarketing study commitments made with the
Center for Biologics Evaluation and Research (CBER) and with the
Center for Drug Evaluation and Research (CDER). The postmarketing
study commitments on this Web site are those that have been reviewed
for accuracy. It does not include commitments regarding proprietary
information (for example, those to evaluate chemistry or manufacturing
and control issues).
The information included on this site is based on FDA's
postmarketing study commitments database as of October 31, 2008. FDA's
verification of our database is an ongoing process to ensure its
accuracy. We will publish additional postmarketing study commitments
as they are verified. Additions and status changes will also appear in
the quarterly updates. To find out what information you can retrieve
from this site, see question number 11. back
to FAQ list
3. Where does the
information on this site come from?
Information about postmarketing study commitments comes from Agency
letters and from annual status reports submitted by applicants.
Information will be verified for accuracy before it is posted on the
Web site. back to FAQ list
4. How often will
the Web site be updated?
The Web site will be updated in January, April,
July, and October.
back to FAQ list
5. Can a product
have more than one commitment related to it?
Yes, there can be more than one commitment related to
the approval of an original new drug application (NDA) or biologics
license application (BLA), as well as more than one commitment related
to subsequent supplemental application approvals. back
to FAQ list
6.
Does CDER require applicants to submit an annual report?
21 CFR 314.81 requires an applicant to submit an annual report
for every approved NDA and every abbreviated new drug application
(ANDA). back to FAQ list
7. Does CBER
require applicants to submit an annual report?
The regulations require annual reports for products
marketed under a BLA for:
- certain changes made to the application (21 CFR 601.12(d))
- summaries on submissions related to pediatric studies (21 CFR
601.28)
- status reports on postmarketing study commitments related to
clinical safety, clinical efficacy, clinical pharmacology, or
nonclinical toxicology (21 CFR 601.70)
Routine annual reports, such as those required under NDA or ANDA
regulations, are not mandatory for licensed biological products. back
to FAQ list
8.
When and how often must an applicant submit an annual status report to
FDA?
An applicant must submit an annual report each year within 60
days after the anniversary date of U.S. approval of the
application. The annual status report is required for all
applications with open commitments until we notify the applicant, in
writing, that all postmarketing study commitments established under
the application(s) have either been fulfilled or that the applicant is
released from the commitments. Separate annual reports are not
required for supplemental applications; therefore, the annual report
due date will be based upon the anniversary date for the original
application approval date. An annual status report can address more
than one commitment for a particular NDA, BLA, or ANDA. back
to FAQ list
9. How
soon will information from the latest annual status report appear on
the Web site?
Updates to postmarketing study commitments based on new information
from the annual status report may not always appear in the same
quarter they are submitted to the Agency. Publishing delays may occur,
depending on when an annual status report is submitted and when the
information is verified. The current information included on this site
is based on the FDA's postmarketing study commitments database as of October 31, 2008, and will change as data are updated quarterly.
back to FAQ list
10. How can
I search the Postmarketing Study Commitment database?
You can search by:
- Center: Select CDER or CBER or both.
- Applicant: Enter the name (or part of the name) of a
company.
- Product: Enter the name or active ingredient (or part of the
name or ingredient).
- NDA/ANDA/BLA Number: Enter the entire
number. Do not include a hyphen in the application number.
- Commitment Status: Select from the menu; the default is "All
Statuses."
- Commitment Required Under: Check specific
types of required commitments if you would like to limit your search
to them.
- NDA/ANDA/BLA Approval Date: Enter a
range of dates.
You can limit the number of records you retrieve by providing very
specific information (such as the NDA/ANDA/BLA
number), or you can retrieve more records by searching on more general
terms (such as commitment status = "ongoing").
However, all search fields are optional.
Search the Postmarketing Studies Commitments Database back
to FAQ list
11. What will I see in
my search results?
If your search criteria match some information in a record, you
will see a screen telling you how many application or supplement
records you retrieved. One application/supplement record appears
on each page, and it will have one or more commitments listed below
it.
The following fields can appear on a Search Results page:
Application/Supplement Information:
- Applicant: The name of the applicant (e.g., a company name)
- Product: The name of the product followed by the active
ingredient
- NDA/ANDA/BLA Number: NDA and ANDA numbers consist of five
digits. BLA numbers consist of six digits.
- Supplement Number: This appears only for supplemental
applications
- NDA/ANDA/BLA Approval Date: The date the product was originally
approved by FDA
- Annual Report Due Date: The date the next report is due
- Annual Report Received: The date FDA received the latest annual
report
Commitment Information:
- Commitment Number: This is the number as it appears in Agency
letters. It does not refer to the commitment's position on the
search results page.
- Commitment Required Under: This appears only for commitments
that are required. (See questions number 12,
13, and 14)
- Original Projected Completion Date: This appears only for
studies where this information is available. (See question number
15)
- Commitment Description
- Current Status: There are seven categories: "pending,"
"ongoing," "delayed," "terminated," "submitted, "fulfilled"
and "released." (See the definitions
of status categories)
- Explanation of Status: This appears only for “delayed” and
“terminated” studies. (See question number 17) back
to FAQ list
12. What is
meant by "Commitment Required Under: Accelerated Approval" in the
search results display?
On December 11, 1992, FDA published the final rule to
accelerate the approval of new drugs for serious and life-threatening
diseases when the drug provides meaningful therapeutic benefit over
existing products. Under these procedures, FDA may approve drugs based
on surrogate endpoints that reasonably predict that a drug provides
clinical benefit. This clinical benefit is then confirmed through
additional human studies that will be completed after marketing
approval (i.e., required postmarketing study commitment).
back to FAQ list
13. What is
meant by "Commitment Required Under: Animal Efficacy Rule" in the
search results display?
On May 31, 2002, FDA published the final rule to allow
use of animal data for evidence of the drug’s effectiveness for
certain conditions when the drug cannot be ethically or feasibly
tested in humans. In these situations, certain new drug and biological
products used to reduce or prevent the toxicity of chemical,
biological, radiological, or nuclear substances may be approved for
marketing based on evidence of effectiveness derived from appropriate
studies in animals and any additional supporting data. Under this
rule, the applicant shall conduct postmarketing studies to verify and
describe the drug’s clinical benefit when such studies are feasible
and ethical. Such postmarketing studies may not be feasible until an
exigency arises that necessitates use of the product.
back to FAQ list
14. What is
meant by "Commitment Required Under: Pediatric Research Equity Act" in
the search results display?
On December 3, 2003, President Bush signed the
Pediatric Research Equity Act of 2003 to improve the quality of
pediatric information in drug labeling. This legislation provides FDA
with explicit authority to require applications for new active
ingredients, new indications, new dosage forms, new dosing regimens,
or new routes of administration to include pediatric studies. The act
further authorizes FDA to require pediatric studies of marketed drugs
that are not adequately labeled for children after other opportunities
to obtain such studies on a voluntary basis have been exhausted. The
requirement for such studies may be waived if necessary studies in
children are impossible, there is strong evidence suggesting the drug
will not be effective or safe in children, the drug does not represent
a meaningful therapeutic benefit over existing therapies for children,
or the drug is not likely to be used in a substantial number of
children. Such studies may also be deferred if the drug is ready for
approval in adults before pediatric studies are completed or due to
concerns about the safety or effectiveness of the drugs in pediatric
populations. When such studies are deferred, they will be treated as
required postmarketing study commitments under 21 CFR 314.81 and
601.70. back to FAQ list
15.
Why do some products have an "Original Projected
Completion Date" while others do not?
An applicant may have included a schedule for
completing a study or studies with their first annual status report
after the implementation of section 506B of the Act, but FDA did not
begin capturing "Original Projected Completion Dates" in the database
until April 2001. If you do not see a date in the "Original Projected
Completion Date" field, that information is currently not available
for that postmarketing study commitment. back to FAQ
list
16.
What do brackets [ ] mean in the text of the
commitments?
Under the Freedom of Information Act (5 U.S.C. 552) (FOIA), certain
information in Agency records may not be released to the public. The
brackets in the text of the postmarketing study commitments mean that
some information was removed — or redacted — from the commitment
because the information may not be released under FOIA. back
to FAQ list
17. Does the site
include an explanation of the status for a particular commitment?
The "Explanation of Status" is a brief explanation about how the
study is progressing in reference to the original projected study
schedule. The explanation of status is displayed on the Web site
for "delayed" and "terminated" studies only. If the explanation
of status provided by the sponsor in their annual status report has
not yet been verified by FDA, the text for this field will read "The
explanation of status has not yet been verified." If the sponsor
has not provided an explanation of status in their annual status
report, the text for this field will read "An explanation of status
was not provided in the annual status report." back to
FAQ list
18. What do the
"Commitment Status" categories mean?
Status Categories
Pending: The study has not been initiated (i.e., no
subjects have been enrolled or animals dosed), but does not meet
the criterion for delayed (i.e., the original projected
date for initiation of patient accrual or initiation of animal
dosing has not passed).
Ongoing: The study is proceeding according to, or is
ahead of, the original schedule. The FDA considers a study to be
ongoing until a final study report is submitted to the FDA, as
long as the activities are proceeding according to the original
study schedule. If patient accrual or animal dosing has started
but is not complete, and the projected date for completion of that
milestone has passed, the study should be categorized as
delayed.
Delayed: The progression of the study is behind the
original study schedule. Delays can occur in any phase of the
study, including patient enrollment, analysis of study results, or
submission of the final study report to the FDA. While the
original study schedule — not a revised schedule — serves as the
basis for defining a study as delayed, each phase of the study
will be considered in its own right. If the applicant has one
delayed phase, but gets back on schedule during the next phase,
the delayed status will no longer apply.
Terminated: The applicant ended the study before
completion, and has not yet submitted a final study report to the
FDA.
Submitted: The applicant has concluded or terminated the
study and has submitted a final study report to the FDA, but FDA
has not yet notified the applicant in writing that the study
commitment has been fulfilled or that the commitment has been
released.
Fulfilled: The applicant has submitted the final study report
for the commitment, and upon review of the final study report, FDA
is satisfied that the applicant has met the terms of the
commitment.
Released: FDA has informed the applicant that it has been
released from its obligation to conduct the postmarketing study
because the study is either no longer feasible or would no longer
provide useful information.
Note: The "fulfilled" and "released" commitments will be
displayed on the Web site for not more than one year from the date
the commitments are fulfilled or released. back
to FAQ list
19. How can
I get a copy of a postmarketing study commitment protocol or final
report?
Protocols and final study reports can be requested either directly
from the applicant or from FDA under the Freedom of Information Act (5
U.S.C. 552) (FOIA). Because information contained in these documents
may be proprietary in nature, your request may be denied or
information in the documents may be redacted.
back to FAQ list
20. How can
I download a data file containing the information displayed on this
Web site?
To obtain a data file of all of the information posted on this Web
site, click on the “Downloadable Database File” hyperlink at the bottom
of the search screen and follow the instructions provided. This will
allow you to download a compressed data file of the PMC information
publicly posted on this Web site.
back to FAQ list
21. Whom can I contact if I have more
questions?
If you have any questions or comments related to Postmarketing
Study Commitments or this Web site, please send them to the
Postmarketing Study Commitment Coordinator at
pmcweb@fda.hhs.gov.
back to FAQ list
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Date created: May 20, 2003 ; Last Updated:
October 31, 2008 |
