Module 12 2019

Data Standards and FDA Meetings

Sponsors can use established FDA-sponsor meetings (e.g., pre- IND, end-of-phase X) to raise data standardization issues

Discussions about non-clinical study data standardization plans can be initiated at the pre-IND stage

Initial discussions about which data standards to use for clinical study data should take place as early as possible

Should occur no later than the EOP2

In general, the premarketing application meeting is considered too late to initiate data standardization discussions

The Organisation for Professionals in Regulatory Affairs