Record retention requirements ensure regulatory access to data even after development is discontinued.
* 21 CFR 312.62(c):"An investigator shall retain records... for2 years after the date a marketing application is withdrawn or discontinuedand FDA is notified."
* In this case, development was terminated15 May 2019. Therefore, the 2-year clock starts at discontinuation. Two years later is15 May 2021, but FDA requires records to be maintaineduntil after the 2-year period ends. Theearliest permissible destruction date is 16 May 2022 (C).
Options A and B are premature; D (2034) is far beyond requirements.
Thus, the correct answer isC (16 May 2022).
References:
21 CFR 312.62(c) (Investigator record retention).
21 CFR 312.57(c) (Sponsor record retention).