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FDA’s OPQ, OCP Tout 2019 Highlights in New Reports

Posted 10 February 2020 | By Michael Mezher 

FDA’s OPQ, OCP Tout 2019 Highlights in New Reports

Two offices within the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), the Office of Pharmaceutical Quality (OPQ) and Office of Clinical Pharmacology (OCP), as well as the Division of Applied Regulatory Science within OCP, highlighted achievements on Monday within their 2019 annual reports.
OPQ’s 2019 annual report is the third released since the office was established in 2015. Highlights include that OPQ participated in or led 30% of the 357 preapproval inspections carried out by FDA in 2019 and that the office expedited 194 quality assessments during the year to avert potential drug shortages.
The report notes that FDA has now approved seven applications for products made using continuous manufacturing, which compares with none approved before 2015.
The report also points out that beginning in 2019, as laid out in FDA’s Concept of Operations, most manufacturers receive notice of inspection results within 90 days and that the agency has cut the time it takes to issue warning letters from one year to about six months.
“These improvements greatly reduce uncertainty for pharmaceutical manufacturing facilities while also allowing the FDA to act more quickly to protect patients from potential risks,” OQP says.
In response to CDER’s Office of New Drugs (OND) reorganization in 2019, OPQ says it created 25 new work units to more closely align with OND’s new structure and renamed some existing units.
OPQ also held a Pharmaceutical Quality Symposium in 2019 which drew more than 2,200 attendees, a third of which who were located outside the US.
OPQ notes how in 2019, the US and EU were able to fully implement their mutual recognition agreement on good manufacturing practice (GMP) inspections after FDA confirmed the capabilities of the remaining EU member states’ regulatory authorities.
“In 2019 alone, the FDA was able to reduce 25% of routine surveillance inspections in the European Union because of reliance on trusted partner reports through this agreement,” FDA writes.
The report also addresses FDA’s quality metrics initiative, noting that 25 OPQ staff visited 15 manufacturing sites around the world as part of its quality metrics site visit program to “better understand how they use quality metrics and establish quality culture programs.”
In OCP’s annual report, the office touts its contributions to clinical pharmacology within FDA and in the scientific literature, and provides an overview of the office’s model-informed drug development (MIDD) pilot program.
“The MIDD regulatory meeting pilot program offered an opportunity for interdisciplinary FDA staff engagement to foster the science and improve outcomes in drug development through early and focused discussions on modeling and simulation,” writes OCP Director Issam Zineh.
In 2019, OCP says it led the development of six clinical pharmacology guidance documents and contributed to the development of 24 multidisciplinary guidances. OCP staff also conducted 138 research projects and published 155 manuscripts in 2019, with nearly a third of those publications relating to mitigating risks to patients.
OCP also says its staff conducted approximately 2,400 reviews for new drug applications, biologics license applications and investigational new drug (IND) submissions in 2019 and held more than 2,000 IND meetings.
Additionally, OCP staff assisted with 53 review-related consults with other branches at FDA, covering topics such as clinical pharmacology development plans, labeling claims, promotional material content, assessment of safety signals and toxicity evaluations.
Division of Applied Regulatory Science
In addition, OCP’s Division of Applied Regulatory Science in its annual report touts its work on applied research, noting that its study on the absorption of sunscreen ingredients was the most viewed article published in JAMA in 2019.
“We continue to develop and validate in vitro and in silico models to improve assessment of drug safety, including liver and health microphysiological systems and improved quantitative structure activity relationship (QSAR) models to assess mutagenicity of drug impurities,” writes Division Director David Strauss.
In 2019, the division says it launched a panorama-based consultation process for ANDA and drug master file (DMF) reviews, as well as a QSAR database with structure-based search capabilities for CDER reviewers.
The division also completed 21 interagency consultations addressing five topics: safety, bioanalytical, safety, clinical pharmacology, labeling and drug-drug interaction.
Annual Reports: Office of Pharmaceutical Quality, Office of Clinical Pharmacology, Division of Applied Regulatory Science


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