The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) on Thursday released its 2018 annual report touting its accomplishments in a year that saw record numbers of new and generic drug approvals.
OPQ is the office responsible for quality assessments for investigational new drug applications (INDs) and all marketing applications reviewed by the Center for Drug Evaluation and Research (CDER), including new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs) and 351(k) applications for biosimilar products.
In 2018, OPQ performed quality assessments for 4,399 INDs and 8,254 postapproval supplements, as well as quality assessments for the 123 NDA approvals, 1,021 ANDA approvals and 24 BLA approvals during the year.
FDA also points out that while OPQ carried out quality assessments for approved ANDAs in 2018, the office also carried out quality assessments for the 2,390 ANDAs that received complete response letters that year.
2018 was the first full year for FDA’s pre-ANDA program
, which is meant to assist sponsors of complex generic drugs. FDA says it held 40 pre-ANDA meetings during the year and relied on research conducted by OPQ on complex drugs throughout their lifecycle to help in the assessment of generics for those products.
In 2018, OPQ published its risk-based site selection model detailing how it selects which facilities to inspect. During the year OPQ conducted 119 facility inspections and readied 710 site dossiers to go be used in facility assessments. OPQ also carried out 52 inspections of BLA facilities (15 domestic and 37 international) in 2018.
According to FDA, OPQ also helped avert potential drug shortages in 2018 by conducting 125 accelerated or priority quality assessments for products at risk of being in shortage.
2018 saw two new developments for FDA’s quality metrics program, the launch of the quality metrics feedback program and the quality metrics site visit program. The agency says it received 15 applications to participate in the site visit program and completed one site visit during the year.
FDA also emphasized OPQ’s contribution to new technologies, noting that the agency approved two new products made using continuous manufacturing
in 2018 and said the office held 27 meetings with companies developing emerging technologies through its emerging technology program
Additionally, OPQ published 17 draft and final guidances in 2018 and OPQ contributed to the scientific literature with the publication of 149 peer-reviewed papers by OPQ staff.