 |
Sample of a General Written Request
This is a sample Written Request template which the
Agency is using to develop its Written Request for
pediatric studies the Agency believes will provide a
meaningful health benefit to the pediatric population. An
actual Written Request may differ from this sample
depending upon the nature of the specific drug product
and any other indications for which it is used. To
receive a formal Written Request for pediatric studies
under section 505A of the Federal Food, Drug, and
Cosmetic Act for a particular drug, please submit a
proposed pediatric study request to the appropriate
Division. The proposed pediatric study request should
incorporate the material in this sample and include
descriptions of any other studies necessary to provide a
meaningful health benefit to pediatric populations.
Please refer to the outline in the "Guidance For Industry
- Qualifying for Pediatric Exclusivity Under Section 505A
of the Federal Food, Drug, and Cosmetic Act," for
additional information.
IND/NDA APPLICATION NUMBER(S)
WRITTEN REQUEST
SPONSOR
Attention: CONTACT, TITLE
ADDRESS
Dear CONTACT:
Reference is made to your INSERT DATE Proposed Pediatric
Study Request submitted to APPLICATION NUMBER(S) for DRUG
PRODUCT(S).
To obtain needed pediatric information on ACTIVE MOIETY,
the Food and Drug Administration (FDA) is hereby making a
formal Written Request, pursuant to Section 505A of the
Federal Food, Drug, and Cosmetic Act (the Act), that you
submit information from the following STUDY/STUDIES:
COMPLETE AND INCLUDE ALL APPROPRIATE SECTIONS
• Type of study(ies): (e.g., double-blind, randomized,
parallel group, safety, and/or pk)
• Indication(s) to be studied (i.e., objective of each
study):
• Age group in which study(ies) will be performed:
INDICATE SPECIFIC AGE RANGE
• Study endpoints
• Drug information
• dosage form
• route of administration
• regimen:
• Use an age-appropriate formulation in the study(ies)
described above. If the studies you conduct in response
to this Written Request demonstrate this drug will
benefit children, then an age-appropriate dosage form
must be made available for children. This requirement can
be fulfilled by developing and testing a new dosage form
for which you will seek approval for commercial
marketing. If you demonstrate that reasonable attempts to
develop a commercially marketable formulation have
failed, you must develop and test an age appropriate
formulation that can be compounded by a licensed
pharmacist, in a licensed pharmacy, from commercially
available ingredients.
Development of a commercially-marketable formulation is
preferable. Any new commercially marketable formulation
you develop for use in children must meet agency
standards for marketing approval.
If you cannot develop a commercially marketable
age-appropriate formulation, you must provide the Agency
with documentation of your attempts to develop such a
formulation and the reasons such attempts failed. If we
agree that you have valid reasons for not developing a
commercially marketable, age-appropriate formulation,
then you must submit instructions for compounding an
age-appropriate formulation from commercially available
ingredients that are acceptable to the Agency. If you
conduct the requested studies using a compounded
formulation, the following information must be provided
and will appear in the product label upon approval:
active ingredients, diluents, suspending and sweetening
agents; detailed step-by-step compounding instructions;
packaging and storage requirements; and formulation
stability information.
Bioavailability of any formulation used in the studies
should be characterized, and as needed, a relative
bioavailability study comparing the approved drug to the
age appropriate formulation may be conducted in adults.
• Drug specific safety concerns:
• Statistical information, including power of study and
statistical assessments:
• Labeling that may result from the study(ies):
Appropriate sections of the label may be changed to
incorporate the findings of the studies.
• Format of reports to be submitted: Full study reports
not previously submitted to the Agency addressing the
issues outlined in this request with full analysis,
assessment, and interpretation. In addition, the reports
are to include information on the representation of
pediatric patients of ethnic and racial minorities. All
pediatric patients enrolled in the study(ies) should be
categorized using one of the following designations for
race: American Indian or Alaska Native, Asian, Black or
African American, Native Hawaiian or other Pacific
Islander or White. For ethnicity one of the following
designations should be used: Hispanic/Latino or Not
Hispanic/Latino. INCLUDE OTHER INFORMATION AS APPROPRIATE
• Timeframe for submitting reports of the study(ies):
Reports of the above studies must be submitted to the
Agency on or before INSERT DATE. Please keep in mind that
pediatric exclusivity attaches only to existing patent
protection or exclusivity that has not expired at the
time you submit your reports of the studies in response
to this Written Request.
• Response to Written Request: As per the Best
Pharmaceuticals for Children Act, section 4(A), within
180 days of receipt of this Written Request you must
notify the Agency as to your intention to act on the
Written Request. If you agree to the request then you
must indicate when the pediatric studies will be
initiated.
Please submit protocols for the above studies to an
investigational new drug application (IND) and clearly
mark your submission "PEDIATRIC PROTOCOL SUBMITTED FOR
PEDIATRIC EXCLUSIVITY STUDY" in large font, bolded type
at the beginning of the cover letter of the submission.
Notify us as soon as possible if you wish to enter into a
written agreement by submitting a proposed written
agreement. Clearly mark your submission "PROPOSED WRITTEN
AGREEMENT FOR PEDIATRIC STUDIES" in large font, bolded
type at the beginning of the cover letter of the
submission.
Reports of the studies should be submitted as a New Drug
Application (NDA) or as a supplement to your approved NDA
with the proposed labeling changes you believe would be
warranted based on the data derived from these studies.
When submitting the reports, please clearly mark your
submission "SUBMISSION OF PEDIATRIC STUDY REPORTS -
PEDIATRIC EXCLUSIVITY DETERMINATION REQUESTED" in large
font, bolded type at the beginning of the cover letter of
the submission and include a copy of this letter. Please
also send a copy of the cover letter of your submission,
via fax (301-594-0183) or messenger to the Director,
Office of Generic Drugs, HFD-600, Metro Park North II,
7500 Standish Place, Rockville, MD 20855-2773.
In accordance with section 9 of the Best Pharmaceuticals
for Children Act, Dissemination of Pediatric Information,
if a pediatric supplement is submitted in response to a
Written Request and filed by FDA, FDA will make public a
summary of the medical and clinical pharmacology reviews
of pediatric studies conducted. This disclosure, which
will occur within 180 days of supplement submission, will
apply to all supplements submitted in response to a
Written Request and filed by FDA, regardless of the
following circumstances:
1. the type of response to the Written Request (complete
or partial);
2. the status of the supplement (withdrawn after the
supplement has been filed or pending);
3. the action taken (i.e. approval, approvable, not
approvable); or
4. the exclusivity determination (i.e. granted or
denied).
FDA will post the medical and clinical pharmacology
review summaries on the FDA website at http://www.fda.gov/cder/pediatric/Summaryreview.htm
and publish in the Federal Register a notification of
availability.
If you wish to discuss any amendments to this Written
Request, submit proposed changes and the reasons for the
proposed changes to your application. Submissions of
proposed changes to this request should be clearly marked
"PROPOSED CHANGES IN WRITTEN REQUEST FOR PEDIATRIC
STUDIES" in large font, bolded type at the beginning of
the cover letter of the submission. You will be notified
in writing if any changes to this Written Request are
agreed upon by the Agency.
As a reminder, you are responsible for compliance with
section 113 of the Food and Drug Administration
Modernization Act of 1997 and section 15 of the Best
Pharmaceuticals for Children Act of 2002 by registering
certain clinical trials in the Clinical Trials Data Bank
(http://clinicaltrials.gov/). If your drug is for the treatment of a serious or
life-threatening disease or condition and you are
conducting trials to test its effectiveness, then you
must register the trials. Although not required, we
encourage you to register trials for non-serious
diseases. For additional information on registering your
clinical trials, including the required and optional data
elements, refer to the Protocol Registration System (PRS)
Information Site (http://prsinfo.clinicaltrials.gov)
and FDA's Guidances for Industry entitled "Information
Program on Clinical Trials for Serious or
Life-Threatening Diseases and Conditions" (March 2002;
revised draft January 2004).
If you have any questions, call NAME, Project Manager, at
PHONE NUMBER.
Sincerely,
OFFICE DIRECTORS SIGNATURE BLOCK
Back to Top 
Back to Pediatric Drug Development
Date created: May 10, 2004; Updated February 28,
2005 |
|
