OPQ Conducts More Remote Preapproval Inspections in 2022

Despite continuing pandemic conditions, the FDA’s Office of Pharmaceutical Quality (OPQ) was able to conduct 65 on-site pre-license inspections in 18 countries in 2022 — up from 47 in 2021 — and used remote regulatory assessments to gather information needed to move forward on 85 more submissions, according to OPQ’s just-released annual report.
Source: Drug Industry Daily