5.12 Information on Investigational Product(s)

5.12.1 When planning trials, the sponsor should ensure that sufficient safety and efficacy data from nonclinical studies and/or clinical trials are available to support human exposure by the route, at the dosages, for the duration, and in the trial population to be studied.

5.12.2 The sponsor should update the Investigator’s Brochure as significant new information becomes available (see 7. Investigator’s Brochure).