BLA 761108/S-021
Page 5
the assessment instruments and methodology with the following wording in bold capital letters at the top of the first page of the submission:
- BLA 761108 REMS ASSESSMENT METHODOLOGY
(insert concise description of content in bold capital letters, e.g.,
ASSESSMENT METHODOLOGY, PROTOCOL, SURVEY METHODOLOGIES,
AUDIT PLAN, DRUG USE STUDY)
Prominently identify any submission containing the REMS assessments or proposed modifications of the REMS with the following wording in bold capital letters at the top of the first page of the submission as appropriate:
- BLA 761108 REMS ASSESSMENT
- or
- NEW SUPPLEMENT FOR BLA 761108/ S-000
CHANGES BEING EFFECTED IN 30 DAYS
PROPOSED MINOR REMS MODIFICATION
- or
- NEW SUPPLEMENT FOR BLA 761108/ S-000
PRIOR APPROVAL SUPPLEMENT
PROPOSED MAJOR REMS MODIFICATION
- or
- NEW SUPPLEMENT FOR BLA 761108/ S-000
PRIOR APPROVAL SUPPLEMENT- PROPOSED REMS MODIFICATIONS DUE TO SAFETY LABELING
CHANGES SUBMITTED IN SUPPLEMENT XXX
- PROPOSED REMS MODIFICATIONS DUE TO SAFETY LABELING
- or
- NEW SUPPLEMENT (NEW INDICATION FOR USE)
FORBLA 761108/ S-000- REMS ASSESSMENT
PROPOSED REMS MODIFICATION (if included)
- REMS ASSESSMENT
Should you choose to submit a REMS revision, prominently identify the submission containing the REMS revisions with the following wording in bold capital letters at the top of the first page of the submission:
- REMS REVISIONS FOR BLA 761108
U.S. Food and Drug Administration
Silver Spring, MD 20993
www.fda.gov
Reference ID: 5019210
