Sponsor must maintain drug disposition records for how long after marketing approval?
A.
1 year
B.
2 years
C.
3 years
D.
5 years
The Answer Is:
B
This question includes an explanation.
Explanation:
21 CFR 312.57(c):“Sponsors shall retain records for2 years after a marketing application is approvedor if not approved, 2 years after shipment and delivery of investigational drug for investigation.”
[References:21 CFR 312.57(c)., ]
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