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Guidance for the Submission of Investigator's Drug Brochures (IDBs) and Package Inserts
Version Date: May 21, 2018
- affect the risk/benefit ratio of the study (i.e., will result in a change to the study documents);
- affect alternatives to study participation for subjects; OR
- represent new information that should be provided to subjects.
- The revised IDBs/Package Inserts do NOT contain revisions that (1) affect the risk/benefit ratio of the study for study subjects (i.e., will result in a change to study documents); (2) affect alternatives to study participation for subjects; or (3) represent new information that should be provided to subjects; or
- The information contained in the revised IDBs and/or package inserts has already been assessed by the IRB (e.g., through a change of protocol); or
- The study is permanently closed to enrollment locally, no local subjects are on treatment, and the revised IDB and/or package insert contains no new information that would affect past subjects (e.g. new latent risks).