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.