REQUEST FOR SPECIAL PROTOCOL ASSESSMENTPhase 3 Clinical Protocol

Date

Address

Subject: IND _______ SN___, _______________

Dear Dr. ____________,

This IND amendment contains a phase 3 clinical protocol, Study __________, that will form the primary basis for an efficacy claim for approval of _________, filed under ______________, for treatment of _____________.

On _DATE_, _COMPANY NAME_ met with the Office to discuss PROGRAM in an ENTER TYPE OF MEETING (SHOULD BE END OF PHASE 2 TYPE MEETING TO MEET GUIDELINE REQUIREMENT FOR SPA REQUEST.

At the meeting, the Office suggested that ____. It was recommended that ____ submit the new protocol for review as a Special Protocol Assessment, provided under section 505(b)(4)(B) of the Act.

In addition to protocol __________, this submission includes a brief discussion of the critical design features and rationale for the study, specific questions, and an Appendix of data from ______ that was used to select the ____________, endpoints, and sample size for the new study.

Dr. Page 2

____ goal is to design a study that will provide adequate data on which the Office could base approval of a BLA submitted under _________ for DRUG NAME in treatment of INDICATION.

COMPANY NAME understands that if the protocol is reviewed under this guidance, Office comments will be provided in writing in a special protocol assessment letter within 45 calendar days of receipt of the protocol. To facilitate an expeditious resolution of any issues, we suggest that during protocol review, direct contact between Office reviewers and COMPANY NAME staff might be helpful. COMPANY NAME clinical, regulatory, and statistical team members will be available to assist Office reviewers in any way during review of this protocol. Please contact ENTER CONTACT NAME, AND CONTACT INFORMATION to assist in coordinating any communications.

With best regards,

Enclosure

CC: Via facsimile TO

COMPANY NAME.Special Protocol Assessment Package

CONFIDENTIAL Investigational New Drug ApplicationIND _________/SN__

Table of Contents

1. Role of Study INSERT STUDY TITLE in the Overall Development of INSERT DRUG NAME....................................................................................................................7

2. Supporting Information....................................................................................................7

2.1 Background InformationStudy _________.......................................................7

2.2 Study INSERT STUDY NAME AND NUMBER..............................................7

2.2.1 Study Design/Patient PopulationProtocol ___ Sections ____ and ___...............7

2.2.2 Study Efficacy EndpointsProtocol ____ Sections __ and ___.............................7

2.2.3 Study Sample SizeProtocol __ Section ____.......................................................7

2.2.4 Heading 3..............................................................................................................7

2.2.5 Heading 3..............................................................................................................8

2.2.6 Heading 3..............................................................................................................8

3. Regulatory Outcome..........................................................................................................8

4. References...........................................................................................................................8

No table of figures entries found.

COMPANY NAME.Special Protocol Assessment Package

CONFIDENTIAL Investigational New Drug ApplicationIND _________/SN__

1. Role of Study INSERT STUDY TITLE in the Overall Development of INSERT DRUG NAME

Study ___ will form the primary basis for an efficacy claim for approval of ____, filed under section _________, for treatment of ____________.

Question for the Office: Does the Office agree that the results of Study ___, combined with other information available to the Office, will provide the clinical data necessary for FDA to file the BLA submitted for treatment INSERT INDICATION?

2. Supporting Information

2.1 Background InformationStudy _________

2.2 Study INSERT STUDY NAME AND NUMBER

2.2.1 Study Design/Patient PopulationProtocol ___ Sections ____ and ___

Question for the Office: Does the Office agree that?

2.2.2 Study Efficacy EndpointsProtocol ____ Sections __ and ___

.

Question for the Office: Does the Office agree that the study primary (INSERT ENDPOINT) and secondary (INSERT ENDPOINT(S)) endpoints are appropriate and will allow a valid assessment of the efficacy of INSERT DRUG NAME in INSERT INDICATION?

2.2.3 Study Sample SizeProtocol __ Section ____

.

Question for the Office: Does the Office agree with the study sample size calculations?

2.2.4 Heading 3

COMPANY NAME.Special Protocol Assessment Package

CONFIDENTIAL Investigational New Drug ApplicationIND _________/SN__

Question for the Office: Does the Office agree that the planned study is acceptable to support approval?

2.2.5 Heading 3

Question for the Office: Does the Office concur with the planned efficacy analyses for Study ___?

2.2.6 Heading 3

Question for the Office: ?

3. Regulatory Outcome

4. References

COMPANY NAME.Special Protocol Assessment Package

CONFIDENTIAL Investigational New Drug ApplicationIND _________/SN__

APPENDIX A