Download Pre-IND Meeting Request Template

XY Month 200X
Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
5901-B Ammendale Rd.
Beltsville, Md. 20705-1266
Attn: Jane Doe, MD
Director, Division of Something
Type B Meeting Request: Pre-IND Meeting
Dear Dr. Doe:
I am requesting a Pre-IND meeting to discuss a preclinical, product and clinical issues for
Phase I and the overall drug development program for the use of “Drug XY” in the treatment of
“WZ Syndrom”
We have assembled large amount of information on the use of “Drug XY” to treat “ZW
Syndrome” in experimental animals. We have, however, a number of questions that pertain to
the proposed administration of “Drug XY” in the “ZW affected patient population”. The issues
that we wish to discuss and obtain Agency guidance and approval relate to aspects of the
clinical study design (for example) and the choice of endpoints (for example) that could be the
basis of approval for Drug XY in treatment of ZW Syndrome. Enclosed is the required
information relating to this Pre-IND meeting.
Sincerely,
John Doe, MD
Professor, Department of Something
Duke University School of Medicine
Tel: 919 684 xxxx
Fax: 919 684 xxxx
email: [email protected]
Pre-IND Meeting Request Information
1.
Product name
Examples:
 “Drug XY”-name of the drug
 “Biologic XY”-name of the biologic such as vaccine construct for example
2.
Chemical name and structure
Examples:
 “Drug XY is a 24-amino-acid peptide with a sequence:...”
 “Drug XY is a protease inhibitor protein, whose main function is to …”
 “Drug XY is chemically described as (chemical formulation). Drug XY has a molecular
weight (Mr) and empirical formulation is (emp. formulation). The structural formula is
provided below (paste the formula below)”
 Biologic XY is a 1 and 2 region deleted adenoviral vector expressing “this and that”
human cDNA…”
3.
Proposed indication
Treatment for ZW Syndrome
4.
Type of meeting requested.
This is a Type B Meeting Request; Pre-IND meeting. We request that the meeting be a 60
minute teleconference.
5.
Purpose of the meeting
Examples:
 “This meeting is to discuss the design of a clinical study (for example) to study the
safety and effectiveness (for example) of “Drug XY” in the treatment of “ZW
Syndrome” in “such and such” patient population. Initial specific questions relating to
the protocol are listed in Item #8.
 “This meeting is to discuss the overall drug development program including preclinical,
product and clinical issues as well as the study protocol for initial Phase I study for the
treatment of “ZW Syndrome” Specific questions relating to preclinical, product and
clinical protocols are listed in Item #8.
6.
7.
Specific objectives/outcomes expected from the meeting
Example:
“The major objective is to gain a clear understanding of any issues or concerns by the
Agency and the potential options in resolving these issues/concerns in the clinical
protocol.”
Preliminary Agenda
Example
 Introductions
 Discussion of questions submitted
 Discussions of issues identified by the Agency
5 min
20 min
30 min

Summary of conclusions reached at the meeting
5 min
8.
Draft list of questions
Please, list the questions that you wish to discuss with the Agency. The examples of those
you can find in the Section 2.5 in the “Pre-IND Briefing Package Document”
9.
Individuals attending the Pre-IND meeting
Examples:
John Doe, MD, Professor of Something Duke University School of Medicine
Bruce K. Burnett, PhD, RAC, Director of Regulatory Affairs, Duke University
10. Agency staff requested by Sponsor to attend Pre-IND meeting
Jane Doe, MD, Division Director
11. Approximate date that briefing package will be sent to the review division
Example:
The briefing package will be sent at least 30 days prior to the scheduled meeting. The
briefing package will contain the final list of questions, a copy of the clinical protocol and
any other supporting information for the meeting.
12. Suggested dates for Pre-IND meeting
Week of Month XY, 200X;
Week of Month XY, 200X; excluding this and that date.