E6: Information on Investigational Product(s)

Question 1

5.12 - Information on Investigational Product(s)

5.12.1

Answer 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.

Question 2

Information on Investigational Product(s)

5.12.2

Answer 2

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