MEMORANDUM                      DEPARTMENT OF HEALTH AND HUMAN SERVICES

                                                            PUBLIC HEALTH SERVICE

                                                            FOOD AND DRUG ADMINISTRATION

                                                            CENTER FOR DRUG EVALUATION AND RESEARCH

 

DATE:                                    May 29, 2003

 

FROM:                                   Alice Kacuba, R.N., MSN, RAC, Regulatory Project Manager,

for Robert L. Justice, M.D., M.S., Director

Division of Gastrointestinal and Coagulation Drug Products,

HFD-180

 

SUBJECT:                             Briefing Document for the June 25, 2003 Meeting of the Gastrointestinal Drugs Advisory Committee on SerostimŇ [somatotropin  (rDNA origin) for injection] for “the treatment of short bowel syndrome”

 

MEETING TIME:                        8:30AM – 5:00PM

 

MEETING LOCATION:            Marriott Washingtonian Center, The Ballrooms,

9751 Washingtonian Blvd., Gaithersburg, MD

 

Please find enclosed the following items:

Attachment 1:            Medical Officer Review

Attachment 2:            Statistical Review     

The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee.  The FDA background package often includes initial reviews and/or preliminary conclusions and recommendations written by individual FDA reviewers.  These conclusions and recommendations do not necessarily represent the final position of the individual reviewer, nor do they necessarily represent the final position of the FDA. The FDA will not take a final action on the application until input from the advisory committee has been considered and all reviews have been finalized.

 

In order to aid your review of the documents provided by the FDA as well as Serono Inc., we would like to focus on the following topics:

 

·        The number of patients studied;

·        The number of studies conducted;

·        The influence of diet on the outcomes;

·        The primary endpoint (total IPN volume) selected in support of this indication.

 

The final questions will be given to you prior to the actual meeting.

We look forward to your participation and seeing you on June 25, 2003.